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510(k) K821841

MEDIGAS SUCTION/DRAINAGE EQUIPMENT by Linde Div. Union Carbide Corp. — Product Code GCX

K821841 is an FDA 510(k) premarket notification submitted by Linde Div. Union Carbide Corp. for the device "MEDIGAS SUCTION/DRAINAGE EQUIPMENT". The FDA issued a decision of Substantially Equivalent on July 2, 1982. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Linde Div. Union Carbide Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1982
Date Received
June 22, 1982
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 Linde Div. Union Carbide Corp.

  • K882208 — MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES (August 3, 1988)
  • K882209 — MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES (August 2, 1988)
  • K882210 — MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES (June 21, 1988)
  • K832143 — MARK III OXYGEN WALKER SYS. RESERVOIR (August 26, 1983)
  • K823582 — OXYGEN CONCENTRATOR UCC-100 (January 5, 1983)

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