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510(k) K843128

FEMALE URINARY INCONTINENCE SYS by Chesebrough-Pond'S U.S.A. Co. — Product Code KNX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1985
Date Received
August 9, 1984
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 Chesebrough-Pond'S U.S.A. Co.

  • K863866 — RESPIRADYNE II(TM) (January 28, 1987)
  • K862803 — CHESEBROUGH POND'S HYDROCOLLOID DRESSING (November 14, 1986)
  • K851382 — CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING (July 5, 1985)
  • K851383 — BLISTERFILM TRANSPARENT DRESSING (July 5, 1985)
  • K851539 — CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO (June 12, 1985)
  • K843567 — KANGAROO NASOGASTRIC FEEDING TUBE (February 14, 1985)
  • K844186 — CONTINENT STOMA SYSTEM & ACCESSORIES (January 15, 1985)
  • K845010 — CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH (January 15, 1985)
  • K844789 — KANGAROO ACCESS II ENTERAL FEEDING CONTAINER (January 2, 1985)
  • K843139 — ISOLATE ADHESIVE BANDAGE FOR MOIST WOUND (November 8, 1984)

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