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FDA 510(k), K961758, CARASYN HYDROGEL WOUND PRODUCTS
FDA 510(k), K961758, CARASYN HYDROGEL WOUND PRODUCTS
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510(K) Number: K961758
Device Name: CARASYN HYDROGEL WOUND PRODUCTS
Manufacturer: DENNIS R SPARKMAN
Device Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Regulation Number: MGQ
Classification Product Code: 05/03/1996
Date Received: 07/11/1996
Decision Date: SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: CARASYN HYDROGEL WOUND PRODUCTS
Manufacturer: DENNIS R SPARKMAN
Device Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Regulation Number: MGQ
Classification Product Code: 05/03/1996
Date Received: 07/11/1996
Decision Date: SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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