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FDA 510(k), K221585, 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
FDA 510(k), K221585, 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
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$89.00 USD
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$89.00 USD
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510(K) Number: K221585
Device Name: 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
Manufacturer: Margaret Marsh
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: KXA
Date Received: 06/01/2022
Decision Date: 03/23/2023
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit
Manufacturer: Margaret Marsh
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: KXA
Date Received: 06/01/2022
Decision Date: 03/23/2023
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
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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