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Okay, so I've tried to find this topic, and haven't had any luck, but if it's out there I'm sorry. It could be that I just don't know where to look exactly, and that I'm having a difficult time rapping my head around this.
The company that I work for, is trying to see if the logistics of this project could work, before jumping in. Something very new. What we are doing is obtaining Alcohol Pads and Gloves (both 510(k)) products from a domestic (US) source, then exporting those to China, where they will be added into a pack with cots sheet and a blanket, then they completed pack will be sent back to the US, where we will sell them.
My question is what information is required for us to have, as far as the FDA is concerned, to re-import these.
Currently we don't have the 510(k) number for either of the products, because we are just a distributor for them.
Any help would be greatly appricaited.
The company that I work for, is trying to see if the logistics of this project could work, before jumping in. Something very new. What we are doing is obtaining Alcohol Pads and Gloves (both 510(k)) products from a domestic (US) source, then exporting those to China, where they will be added into a pack with cots sheet and a blanket, then they completed pack will be sent back to the US, where we will sell them.
My question is what information is required for us to have, as far as the FDA is concerned, to re-import these.
Currently we don't have the 510(k) number for either of the products, because we are just a distributor for them.
Any help would be greatly appricaited.
