510(k) usage - Company has 2 physically similar products

Z

Zumey

Registered
#1
#1
Hi everyone.

There's this situation where a company has 2 physically similar products, a normal and advanced one. The advanced one has 510k number but not the normal one. However, the client wants to import the normal one to USA. Can the company use the advanced's 510k number? The material and intended purpose are the same. It's just the advanced one was safe from a more hazardous chemical.

Thank you
 
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Ronen E

Ronen E

Problem Solver
Staff member
Moderator
#2
#2
Zumey said:
It's just the advanced one was safe from a more hazardous chemical.
Click to expand...
How is this increase in safety achieved?
Is that the only tech difference?

In principle you can't use a 510(k) for a device that's considered as not coming under the cleared scope. To determine whether that is or isn't the case, full details of the device in question and the cleared 510(k) submission are required. Otherwise it's just a guesstimate.
 
Z

Zumey

Registered
#3
#3
Ronen E said:
How is this increase in safety achieved?
Is that the only tech difference?

In principle you can't use a 510(k) for a device that's considered as not coming under the cleared scope. To determine whether that is or isn't the case, full details of the device in question and the cleared 510(k) submission are required. Otherwise it's just a guesstimate.
Click to expand...
Sir, there's confusion in my question and I apologize for that. The products are the same. They have same colour, specifications, physical dimensions but different labeling. This is due to the advanced one has been tested with dangerous substance so it has additional label, compared to the normal one. As far as I've read, only document to file needed because there is no change in safety. What's your opinion?
 
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