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FDA 510(k), K133542, PURACYN PLUS SKIN AND WOUND
FDA 510(k), K133542, PURACYN PLUS SKIN AND WOUND
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510(K) Number: K133542
Device Name: PURACYN PLUS SKIN AND WOUND
Manufacturer: INNOVACYN, INC.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 11/18/2013
Decision Date: 04/28/2014
Regulation Medical Specialty:
Device Name: PURACYN PLUS SKIN AND WOUND
Manufacturer: INNOVACYN, INC.
Device Classification Name: dressing, wound, drug
Regulation Number:
Classification Product Code: FRO
Date Received: 11/18/2013
Decision Date: 04/28/2014
Regulation Medical Specialty:
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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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