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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 E. Henrietta Rd.
Rochester,  NY  14623 -3133
Applicant Contact KARLA BYRNE
Correspondent
Getinge USA, Inc.
1777 E. 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
Predetermined Change
Control Plan Authorized		 No
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