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FDA 510(k), K151436, PICO Single Use Negative Pressure Wound Therapy System
FDA 510(k), K151436, PICO Single Use Negative Pressure Wound Therapy System
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510(K) Number: K151436
Device Name: PICO Single Use Negative Pressure Wound Therapy System
Manufacturer: SMITH & NEPHEW MEDICAL LTD
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 05/28/2015
Decision Date: 01/28/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: PICO Single Use Negative Pressure Wound Therapy System
Manufacturer: SMITH & NEPHEW MEDICAL LTD
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 05/28/2015
Decision Date: 01/28/2016
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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