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510(k) K896726

4 SURE EXTERNAL MALE CATHETER by The Boston & Pacific Co., Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1990
Date Received
November 29, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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

  • K896728 — 4 SURE URINARY LEG BAG (February 20, 1990)
  • K896727 — 4 SURE URINARY DRAIN BAG (February 20, 1990)
  • K896725 — 4 SURE UROLOGICAL CATHETER (February 16, 1990)

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