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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 K070595
Device Name SPORVIEW STEAM SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
Spsmedical Supply Corp.
6789 W. Henrietta Rd.
Rush,  NY  14543
Applicant Contact GARY SOCOLA
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number880.2800
Classification Product Code
FRC  
Date Received03/02/2007
Decision Date 05/24/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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