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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K032723
Device Name BIOSIGN STEAM-24 BIOLOGICAL INDICATOR
Applicant
Getinge USA, Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Applicant Contact KARLA BYRNE
Correspondent
Getinge USA, Inc.
1777 E. Henrietta Rd.
Rochester,  NY  14623
Correspondent Contact KARLA BYRNE
Regulation Number880.2800
Classification Product Code
FRC  
Date Received09/03/2003
Decision Date 10/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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