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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 K023716
Device Name SPSMEDICAL SPORVIEW BACTERIAL SPORE STRIP
Applicant
Spsmedical Supply Corp.
6789 W. Henrietta Rd.
Rush,  NY  14543
Applicant Contact GARY J SOCOLA
Correspondent
Spsmedical Supply Corp.
6789 W. Henrietta Rd.
Rush,  NY  14543
Correspondent Contact GARY J SOCOLA
Regulation Number880.2800
Classification Product Code
FRC  
Date Received11/05/2002
Decision Date 12/05/2002
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
Recalls CDRH Recalls
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