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510(k) K883057

COMFORT CATH MALE EXTERNAL CATHETER by Sierra Laboratories, Inc. — Product Code EYT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1988
Date Received
July 19, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances by Sierra Laboratories, Inc.

  • K970966 — COMFORT CATH CHOICE MALE EXTERNAL CATHETER (April 22, 1997)
  • K962384 — COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER (July 15, 1996)
  • K962413 — COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER (July 15, 1996)
  • K934266 — COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER (April 19, 1994)
  • K934052 — ALPINE REUSABLE LEG BAGS (January 7, 1994)
  • K931156 — CONE CATH (July 1, 1993)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K873039 — MODEL 820 TOP=TRAK (February 11, 1988)
  • K832450 — URO-TEX MALE EXTERNAL CATHETER (October 14, 1983)
  • K811887 — SKIN STAPLE EXTRACTOR (July 27, 1981)

Other clearances for product code EYT

  • K934080 — URINARY DRAINAGE BAG (May 18, 1994)
  • K935774 — CURITY FAST-CATH FEMALE CATHETER KIT (April 11, 1994)
  • K883119 — VPI NON-ADHESIVE CONDOM CATHETER (August 2, 1988)