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FDA 510(k) Application Details - K000718
Device Classification Name
Culture Media, Propagating Transport
More FDA Info for this Device
510(K) Number
K000718
Device Name
Culture Media, Propagating Transport
Applicant
NOVAMED LTD.
28 PIERRE KOENIG ST.,
TALPIOT INDUSTRIAL AREA
JERUSALEM 93469 IL
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Contact
GERALD M SLUTZKY
Other 510(k) Applications for this Contact
Regulation Number
866.2390
More FDA Info for this Regulation Number
Classification Product Code
JSN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/03/2000
Decision Date
08/24/2000
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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