Christine - It appears that most (if not all) opthalmic "spectacle" devices (including sunglasses) are Class I, 510(k)-exempt under 21 CFR 886. You would really only need to create a listing for the appropriate Class I product code(s) under which you determine that your devices would fall. There may only be one (HQY, for example?). Regardless, the listings would be created by Class I, exempt product code in this case and would be independent of the varieties, styles, etc.
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Karl Nittinger
Reading PA
United States
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Original Message:
Sent: 11-19-2014 13:56
From: Christine Posin
Subject: Sunglass Products - Registration & Listing
Our company manufactures finished sunglasses for multiple companies and stores. Each order is for multiple styles and many are custom styles. This is a new company and we are getting ready to register and list for the first time. However, we are not sure how to file the device listing as the models, styles, etc. change with each new order.
Any suggestions?
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Christine Posin RAC
Walnut CA
United States
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