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510(k) K896134

ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. by Goosen Enterprises, Inc. — Product Code GCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 30, 1990
Date Received
October 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Goosen Enterprises, Inc.

  • K923848 — GOOSEN SELF-LUBRICATING CATHETER (February 18, 1994)
  • K896579 — GOOSEN URINARY DRAINAGE SYSTEM (February 15, 1990)
  • K844889 — MENSINK-GOOSEN CATHETER (March 18, 1985)

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  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)