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510(k) K924407

CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH by Coloplast A/S — Product Code EXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1992
Date Received
August 25, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Incontinence, Urosheath Type, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

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Other clearances for product code EXJ

  • K970465 — BOUSER'S URINAL (December 18, 1997)
  • K972100 — VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000) (July 31, 1997)
  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K963265 — PROSYS SAMEC LA (October 25, 1996)
  • K962900 — SELF RETAINING MALE EXTERNAL URINARY CATHETER (September 16, 1996)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K952082 — ROCHESTER MEDICAL CORPORATION SILICONE MALE EXTERNAL CATHETER (July 18, 1995)
  • K945628 — CLEAR ADVANTAGE II (July 6, 1995)
  • K951530 — PROSYS URIHESIVE SYSTEM LA (May 12, 1995)