Classification for Nasal Aspirator (non powered)

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marmotte

Involved In Discussions
#12
Try these (separated by semi-colon)

PRODUCT CODE; Device; Reg; Class
BZE; heater, breathing system w/wo controller (not humi ... ; 868.527; 2
OGG; humidifier nebulizer kit ; 868.545; 2
KFZ; humidifier, non-direct patient interface (home-use ... ; 868.546; 1
BTT; humidifier, respiratory gas, (direct patient inter ... ; 868.545; 2
KCO; inhaler, nasal ; 874.522; 1
CAF; nebulizer (direct patient interface) ; 868.563; 2
CCQ; nebulizer, medicinal, non-ventilatory (atomizer) ; 868.564; 1
JPW; pump, nebulizer, electrically powered ; 874.522; 1
EPN; pump, nebulizer, manual ; 874.522; 1
CAD; vaporizer, anesthesia, non-heated ; 868.588; 2
I have tried those too when searching by keyword in the Access Database, but nothing matches - indications for use AND device are very different.

THX
 

marmotte

Involved In Discussions
#13
Note that:

1. My friend (registered as the specifier) has classified the device under the code CGY - following an informal but written advice (email) from a FDA Officer whom he had contacted! IMHO this was not the right code (Surgery device) - and also surprising that a FDA employee would somehow "bypass" the formal 513(g) route!

2. Trouble is there is a full shipment which has been recently imported from the manufacturer - and the FD has put it on hold because, whereas the specifier was registered, the manufacturer was not :( All this based on the assumption that these products were indeed CGY
At longer term, the plan is to have the manufacturer registered as well for other products. But this will take some time - and in the shorter term I was wondering to what extent we could try to "declassify" this product as being a medical device at all. I have reviewed the instructions for use and labeling carefully, and there aren't any claim that refer to disease, sickness, treatment, therapy etc....
Any idea/advice would be welcome - the hold is quite costly so the faster this can be resolved the better !

What I have found so far:

http://elsmar.com/Forums/showthread.php?p=583192
http://elsmar.com/Forums/showthread.php?t=50487
 
#14
Were you ever able to solve this matter? So far all I can assume is that is exempt from premarket notification 501(k), however, I can't find the exact classification of the product or any mention that it is exempt. I would really appreciate your help.
 
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