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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilizer, Steam
510(k) Number K852114
Device Name ARS ENTERPRISES PRE-VACUUM STEAM STERILIZER 85000
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 Number880.6880
Classification Product Code
FLE  
Date Received05/15/1985
Decision Date 09/27/1985
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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