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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 WEST 23RD ST.
P.O. BOX 620
ERIE,  PA  16514
Applicant Contact MICHAEL J ZMUDA
Correspondent
AMERICAN STERILIZER CO.
2424 WEST 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
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