FDA 510(k), K812615, TM-CAPD

FDA 510(k), K812615, TM-CAPD

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510(K) Number: K812615
Device Name: TM-CAPD
Manufacturer: TRI-MED, INC.
Device Classification Name: peritoneal dialysate filter
Regulation Number: 876.5630
Classification Product Code: KPP
Date Received: 09/15/1981
Decision Date: 01/05/1982
Regulation Medical Specialty: Gastroenterology/Urology
  • 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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