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510(k) K915246

CONVEEN(R) URISHEATH AND URILINER(MALE EXTER CATH) by Coloplast A/S — Product Code EXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1992
Date Received
November 15, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Paste-On For Incontinence, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

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Other clearances for product code EXI

  • K971499 — FEMALE EXTERNAL URINARY COLLECTION POUCH (August 28, 1997)
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  • K963950 — BIODERM EID MALE EXTERNAL INCONTINENCE DEVICE (January 10, 1997)
  • K931277 — HOLLISTER PREMIUM URINE COLLECTOR (June 23, 1993)
  • K924755 — CONVATEC LITTLE ONES PEDIATRIC URINE COLLECTION (June 22, 1993)
  • K915616 — URIHESIVE STRIP (January 23, 1992)