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510(k) K840292

URETHRAL CATH. TRAY W/BAG by Corpak Co. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1984
Date Received
January 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type

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  • K902949 — CORPAK GRASPING FORCEPS (August 30, 1990)
  • K901501 — CORPAK GASTROSTOMY TUBE (June 11, 1990)
  • K882867 — CORPAK PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE (September 21, 1988)
  • K853253 — CORPAK FARRELL VALVE ENTERAL GASTRIC PRESSURE RELI (November 5, 1985)

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  • K971929 — AMSINO URINARY LEG BAG (August 6, 1997)
  • K971764 — WELCON HUE-VU URINARY DRAINAGE BAG (July 29, 1997)
  • K964690 — LIBERTY VALVE (March 21, 1997)
  • K964745 — AMSINO URINARY DRAINAGE BAG (March 18, 1997)
  • K962652 — URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) (October 4, 1996)
  • K960949 — PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (April 19, 1996)