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FDA 510(k) Application Details - K964027
Device Classification Name
Device, Specimen Collection
More FDA Info for this Device
510(K) Number
K964027
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
Other 510(k) Applications for this Contact
Regulation Number
866.2900
More FDA Info for this Regulation Number
Classification Product Code
LIO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/1996
Decision Date
11/01/1996
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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