FDA 510(k) Application Details - K964026

Device Classification Name Device, Specimen Collection

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510(K) Number K964026
Device Name Device, Specimen Collection
Applicant SAGE PRODUCTS, INC.
815 TEK DR.
CRYSTAL LAKE, IL 60014-8172 US
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Contact KAREN PINTO
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Regulation Number 866.2900

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Classification Product Code LIO
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Date Received 10/07/1996
Decision Date 11/07/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee MI - Microbiology
Review Advisory Committee MI - Microbiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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