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FDA 510(k), K110458, SILVER ANTIMICROBIAL WOUND GEL
FDA 510(k), K110458, SILVER ANTIMICROBIAL WOUND GEL
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510(K) Number: K110458
Device Name: SILVER ANTIMICROBIAL WOUND GEL
Manufacturer: CLAIRE RYAN
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 02/17/2011
Decision Date: 03/14/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: SILVER ANTIMICROBIAL WOUND GEL
Manufacturer: CLAIRE RYAN
Device Classification Name: Dressing, Wound, Drug
Regulation Number: FRO
Classification Product Code: KXA
Date Received: 02/17/2011
Decision Date: 03/14/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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