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510(k) K844889

MENSINK-GOOSEN CATHETER by Goosen Enterprises, Inc. — Product Code GBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1985
Date Received
December 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Multiple Lumen
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Goosen Enterprises, Inc.

  • K923848 — GOOSEN SELF-LUBRICATING CATHETER (February 18, 1994)
  • K896134 — ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. (August 30, 1990)
  • K896579 — GOOSEN URINARY DRAINAGE SYSTEM (February 15, 1990)

Other clearances for product code GBP

  • K821220 — MULTILUMEN INTRAVENOUS INFUSION CATHETER (July 9, 1982)
  • K820446 — CATHETER, MULTIPLE LUMEN (March 11, 1982)