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510(k) K852115

ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER by Ars Enterprises, Inc. — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 1985
Date Received
May 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

Other clearances by Ars Enterprises, Inc.

  • K852114 — ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000 (September 27, 1985)
  • K852113 — ARS ENTERPRISES NEW/REMFR'D GP STEAM STERILIZER 81 (September 27, 1985)
  • K831356 — STEAM STERILIZER (July 18, 1984)

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  • K023290 — STERRAD 50 & STERRAD 100S STERILIZERS (April 3, 2003)
  • K905119 — PLAZLYTE(TM) (December 22, 1994)