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510(k) K964219

ZIP CONDOM CATHETER by Goulter Medical, Inc. — Product Code EYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1997
Date Received
October 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Device Class
Class I
Regulation Number
876.5250
Review Panel
GU
Submission Type

Other clearances for product code EYZ

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  • K952780 — URINARY GEL DRAINAGE SYSTEM (December 12, 1995)
  • K951597 — URINARY DRAINAGE BAG (August 4, 1995)
  • K942753 — ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER (November 2, 1994)
  • K933126 — COMFORTCARE SYSTEM (February 25, 1994)
  • K930556 — NIGHT URINARY DRAINAGE BEDSIDE BAG (May 14, 1993)
  • K896695 — DYNA-FLO URINARY DRAINAGE BAG (May 2, 1990)
  • K901000 — URO TEX URINALS (March 26, 1990)
  • K890465 — CLOSED SYSTEM URINARY DRAINAGE BAG (May 23, 1989)
  • K891178 — TECNOL SECURE-ALL TUBE HOLDER (May 23, 1989)