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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 K022706
Device Name SPSMEDICAL SPORVIEW STEAM BI TEST PACK
Applicant
SPS MEDICAL SUPPLY CORP.
6789 WEST HENRIETTA RD.
RUSH,  NY  14543
Applicant Contact GARY J SOCOLA
Correspondent
SPS MEDICAL SUPPLY CORP.
6789 WEST HENRIETTA RD.
RUSH,  NY  14543
Correspondent Contact GARY J SOCOLA
Regulation Number880.2800
Classification Product Code
FRC  
Date Received08/14/2002
Decision Date 10/25/2002
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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