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510(k) K962604

PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING by Convatec, A Division of E.R. Squibb & Sons — Product Code FAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1996
Date Received
July 2, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Urine Collection, Leg, For External Use, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

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  • K974205 — KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON (February 6, 1998)

Other clearances for product code FAQ

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  • K955609 — CONVEEN URINE BAG - STERILE (December 29, 1995)
  • K953767 — PROSYS BEDSIDE DRAINAGE BAG (December 20, 1995)
  • K953783 — CONVEEN LEG BAG STRAP (September 13, 1995)
  • K951945 — PROSYS LEG BAG (May 25, 1995)
  • K945204 — URINE COLLECTOR & ACCESSORIES (November 2, 1994)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931727 — URINARY DRAINAGE BAG CADDY (July 23, 1993)
  • K926035 — BARD LEG BAG HOLDER (December 17, 1992)
  • K924406 — CONVEEN(R) LEG BAG(500 ML) (October 30, 1992)