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FDA 510(k), K083357, OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
FDA 510(k), K083357, OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
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510(K) Number: K083357
Device Name: OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
Manufacturer: CHRISTY H OVIATT
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: 11/13/2008
Date Received: 03/04/2009
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510
Manufacturer: CHRISTY H OVIATT
Device Classification Name: Negative Pressure Wound Therapy Powered Suction Pump
Regulation Number: OMP
Classification Product Code: 11/13/2008
Date Received: 03/04/2009
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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