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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K964027
Device Name STP SYSTEM-PVA WITH MERCURY
Applicant
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014
Applicant Contact KAREN PINTO
Correspondent
Sage Products, Inc.
815 Tek Dr.
Crystal Lake,  IL  60014
Correspondent Contact KAREN PINTO
Regulation Number866.2900
Classification Product Code
LIO  
Date Received10/07/1996
Decision Date 11/01/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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