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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 K122024
Device Name SPSMEDICAL SPORVIEW 10 STEAM SELF CONTAINED BIOLOGICAL INDICATOR
Original Applicant
SPS MEDICAL SUPPLY CORP.
6789 w henrietta rd
industry,  NY  14543
Original Contact gary j socola
Regulation Number880.2800
Classification Product Code
FRC  
Date Received07/11/2012
Decision Date 11/26/2013
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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