FDA 510(k), K921415, IRRIGATION TUBING SET

FDA 510(k), K921415, IRRIGATION TUBING SET

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510(K) Number: K921415
Device Name: IRRIGATION TUBING SET
Manufacturer: PSI MEDICAL PRODUCTS, INC.
Device Classification Name: catheter, urological
Regulation Number: 876.5130
Classification Product Code: KOD
Date Received: 03/24/1992
Decision Date: 09/04/1992
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

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