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FDA 510(k), K150799, Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
FDA 510(k), K150799, Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
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510(K) Number: K150799
Device Name: Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
Manufacturer: INNOVACYN, INC.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 03/26/2015
Decision Date: 11/19/2015
Regulation Medical Specialty:
Device Name: Puracyn(R) Plus Duo-Care(TM) Antimicrobial Wound & Skin Hydrogel, Puracyn(R) Plus Antimicrobial Hydrogel Professional Formula
Manufacturer: INNOVACYN, INC.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 03/26/2015
Decision Date: 11/19/2015
Regulation Medical Specialty:
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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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