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510(k) K851470

BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR by Lic-Orthion — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1985
Date Received
April 15, 1985
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

Other clearances by Lic-Orthion

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  • K854729 — ADAM (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K851471 — TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR (June 12, 1985)
  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
  • K843233 — ANATOM SYSTEM (October 25, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830850 — OB TRIPP TRANSPORT CHAIR (April 5, 1983)
  • K830842 — OB HELP ARM (April 5, 1983)

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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)