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510(k) K821848

ASSURE-MALE EXTERNAL INCONTINCE CATHETER by Medical Design & Manufacturing Corp. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1982
Date Received
June 22, 1982
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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  • K911366 — PROTECTOR DISPOSABLE TENS AND NMES ELECTRODE (September 27, 1991)
  • K902822 — MEDICAL DESIGNS, INC., SPECTRUM II TENS DEVICE (December 19, 1990)
  • K895604 — SOFT-EZ REUSABLE SELF-ADHERING PIGTAIL ELECTRODES (October 13, 1989)
  • K880492 — INTERCEPT T.E.N.S. DEVICE (April 18, 1988)
  • K834138 — HYPO SUTURE (January 27, 1984)
  • K811224 — MINISTIM (June 2, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)

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  • K971271 — BESECURE EXTERNAL URINARY COLLECTION SYSTEM (August 18, 1997)
  • 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)