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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, Liquid Chemical Sterilization Process
510(k) Number K043135
Device Name SPSMEDICAL SPORVIEW PA CULTURE SET
Applicant
Spsmedical Supply Corp.
6789 W. Henrietta Rd.
Rush,  NY  14543
Applicant Contact GARY J SCOLA
Correspondent
Spsmedical Supply Corp.
6789 W. Henrietta Rd.
Rush,  NY  14543
Correspondent Contact GARY J SCOLA
Regulation Number880.2800
Classification Product Code
MRB  
Date Received11/12/2004
Decision Date 01/13/2005
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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