FDA 510(k), K180205, AVELLE Negative Pressure Wound Therapy System

FDA 510(k), K180205, AVELLE Negative Pressure Wound Therapy System

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510(K) Number: K180205
Device Name: AVELLE Negative Pressure Wound Therapy System
Manufacturer: ConvaTec Limited
Device Classification Name: negative pressure wound therapy powered suction pump
Regulation Number: 878.4780
Classification Product Code: OMP
Date Received: 01/24/2018
Decision Date: 10/19/2018
Regulation Medical Specialty: General & Plastic Surgery

 

2019-772 was a first party request -- do not reactivate.

  • 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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