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510(k) K904921

STERI-VAC(TM) AERATOR MODEL XL by 3M Health Care, Ltd. — Product Code FLI

K904921 is an FDA 510(k) premarket notification submitted by 3M Health Care, Ltd. for the device "STERI-VAC(TM) AERATOR MODEL XL". The FDA issued a decision of Substantially Equivalent on December 5, 1990. The device falls under product code FLI (Cabinet, Ethylene-Oxide Gas Aerator), a Class II device regulated under 21 CFR 880.6100. 3M Health Care, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1990
Date Received
October 31, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cabinet, Ethylene-Oxide Gas Aerator
Device Class
Class II
Regulation Number
880.6100
Review Panel
HO
Submission Type

Other clearances by 3M Health Care, Ltd.

  • K953904 — SARNS 9000 UNIVERSAL ROLLER PUMP (April 19, 1996)
  • K926364 — ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X (March 31, 1995)
  • K941534 — MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM (March 6, 1995)
  • K941748 — STERI-VAC GAS STERILIZER MODEL 8XL (December 2, 1994)
  • K930681 — 3M PREVENTION FABRIC SURGICAL GOWN #78XX (February 10, 1994)
  • K932307 — 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM (January 7, 1994)
  • K932422 — 3M TEGADERM HP TRANSPARENT DRESSING (December 27, 1993)
  • K932446 — INJECTION SITE (November 29, 1993)
  • K931968 — CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO (November 10, 1993)
  • K933005 — AVI MODEL 600 SYRINGE PUMP (October 25, 1993)

Other clearances for product code FLI

  • K902906 — GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR (October 15, 1990)
  • K831595 — CASTLE MODEL 3341 & 3441 & 4141 GAS AER (June 15, 1983)
  • K830165 — BEAR JET 150 VENTILATOR (April 12, 1983)
  • K813201 — CASTLE #3241 GAS AERATOR (December 31, 1981)
  • K790677 — EO EVACUATING SYSTEM I (May 7, 1979)
  • K781484 — CASTLE MODEL 3146 GAS AERATOR (October 27, 1978)
  • K761341 — PORTAGAS AERATOR (February 28, 1977)

FDA data resources