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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
Original Applicant
AMERICAN STERILIZER CO.
2424 west 23rd st.
p.o. box 620
erie,  PA  16514
Original 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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