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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K031647
Device Name BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR
Applicant
GETINGE USA, INC
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Applicant Contact KARLA BYRNE
Correspondent
GETINGE USA, INC
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Correspondent Contact KARLA BYRNE
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/27/2003
Decision Date 07/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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