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FDA 510(k), K961085, DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
FDA 510(k), K961085, DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
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510(K) Number: K961085
Device Name: DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
Manufacturer: DEBRA F MANNING
Device Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Regulation Number: MGQ
Classification Product Code: 03/19/1996
Date Received: 05/21/1996
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
Manufacturer: DEBRA F MANNING
Device Classification Name: Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Regulation Number: MGQ
Classification Product Code: 03/19/1996
Date Received: 05/21/1996
Decision Date: Substantially Equivalent (SESE)
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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