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510(k) K771737

SUCTION CANISTER by Bemis Health Care — Product Code GCX

K771737 is an FDA 510(k) premarket notification submitted by Bemis Health Care for the device "SUCTION CANISTER". The FDA issued a decision of Substantially Equivalent on December 20, 1977. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Bemis Health Care has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1977
Date Received
September 15, 1977
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 Bemis Health Care

  • K885019 — BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI. (January 25, 1989)
  • K822557 — SPECIMEN ADAPTOR (October 18, 1982)
  • K822556 — CRITICAL MEASUREMENT UNIT (October 18, 1982)
  • K803206 — SUCTION PROBE (January 21, 1981)
  • K771738 — MALE URINAL (September 28, 1977)
  • K771733 — 8 EMESIS BASIN (September 28, 1977)
  • K760393 — BED PAN, STACKABLE (AUTOCLAVABLE) (August 23, 1976)
  • K760071 — TRAY, PERSONAL, RECTANG. 8 1/2 X 5 1/4 (July 20, 1976)
  • K760070 — TUMBLER, PERSONAL, ROUND, 9 OUNCE (July 20, 1976)
  • K760072 — CARAFE, PERSONAL, 1-QT SEMI-RECTANGULAR (July 20, 1976)

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