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510(k) K896728

4 SURE URINARY LEG BAG by The Boston & Pacific Co., Inc. — Product Code FAQ

K896728 is an FDA 510(k) premarket notification submitted by The Boston & Pacific Co., Inc. for the device "4 SURE URINARY LEG BAG". The FDA issued a decision of Substantially Equivalent on February 20, 1990. The device falls under product code FAQ (Bag, Urine Collection, Leg, For External Use, Sterile), a Class I device regulated under 21 CFR 876.5250. The Boston & Pacific Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 1990
Date Received
November 29, 1989
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

Other clearances by The Boston & Pacific Co., Inc.

  • K896726 — 4 SURE EXTERNAL MALE CATHETER (February 26, 1990)
  • K896727 — 4 SURE URINARY DRAIN BAG (February 20, 1990)
  • K896725 — 4 SURE UROLOGICAL CATHETER (February 16, 1990)

Other clearances for product code FAQ

  • K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZ (July 18, 1996)
  • K960217 — CPR URINE BAG (March 28, 1996)
  • 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)

FDA data resources