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510(k) K780190

CATHETER STRAP & RUINARY BAY HOLDER by Baka Manufacturing Co., Inc. — Product Code FAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1978
Date Received
February 6, 1978
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 Baka Manufacturing Co., Inc.

  • K781800 — GRIP, HOSPITAL UTILITY (December 7, 1978)

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  • 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)