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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 K931872
Device Name THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER
Applicant
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Applicant Contact MICHAEL J ZMUDA
Correspondent
American Sterilizer Co.
2424 W. 23rd St.
P.O. Box 620
Erie,  PA  16514
Correspondent Contact MICHAEL J ZMUDA
Regulation Number880.6860
Classification Product Code
FLF  
Date Received04/14/1993
Decision Date 02/07/1994
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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