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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 K050664
Device Name SPOR-TEST PA BIOLOGICAL INDICATOR KIT
Applicant
GETINGE USA, INC
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Applicant Contact BARD SMITH
Correspondent
GETINGE USA, INC
1777 EAST HENRIETTA RD.
ROCHESTER,  NY  14623 -3133
Correspondent Contact BARD SMITH
Regulation Number880.2800
Classification Product Code
FRC  
Date Received03/15/2005
Decision Date 04/07/2005
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
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