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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 K912471
Device Name EAGLE 3000 SDS
Applicant
Amsco Co.
2424 W. 23rd St.
Erie,  PA  16514
Applicant Contact MICHAEL J ZMUDA
Correspondent
Amsco Co.
2424 W. 23rd St.
Erie,  PA  16514
Correspondent Contact MICHAEL J ZMUDA
Regulation Number880.6880
Classification Product Code
FLE  
Date Received06/04/1991
Decision Date 06/26/1992
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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