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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Ethylene-Oxide Gas
510(k) Number K852115
Device Name ARS ENTERPRISES ETHYLENE OXIDE GAS STERILIZER
Applicant
Ars Enterprises, Inc.
12900 Lakeland Rd.
Santa Fe Springs,  CA  90670
Applicant Contact ELEANOR WANNER
Correspondent
Ars Enterprises, Inc.
12900 Lakeland Rd.
Santa Fe Springs,  CA  90670
Correspondent Contact ELEANOR WANNER
Regulation Number880.6860
Classification Product Code
FLF  
Date Received05/15/1985
Decision Date 11/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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