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510(k) K902089

EQUI-GUARD (ASPIRATOR FILTER) by Equi-Tron Mfg., Inc. — Product Code GCX

K902089 is an FDA 510(k) premarket notification submitted by Equi-Tron Mfg., Inc. for the device "EQUI-GUARD (ASPIRATOR FILTER)". The FDA issued a decision of Substantially Equivalent on July 6, 1990. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Equi-Tron Mfg., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1990
Date Received
May 9, 1990
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 Equi-Tron Mfg., Inc.

  • K962763 — 2000 MODULAR THIRTY-NINE (October 7, 1996)
  • K903904 — SERIES 2000 ADJUSTABLE BED (October 12, 1990)
  • K903905 — SERIES 9000 LIFT-RECLINE CHAIR (September 17, 1990)
  • K894831 — PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 (October 24, 1989)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • 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)

FDA data resources