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510(k) K923848

GOOSEN SELF-LUBRICATING CATHETER by Goosen Enterprises, Inc. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1994
Date Received
July 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Goosen Enterprises, Inc.

  • K896134 — ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. (August 30, 1990)
  • K896579 — GOOSEN URINARY DRAINAGE SYSTEM (February 15, 1990)
  • K844889 — MENSINK-GOOSEN CATHETER (March 18, 1985)

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