FDA 510(k) Application Details - K000718

Device Classification Name Culture Media, Propagating Transport

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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
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Regulation Number 866.2390

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Classification Product Code JSN
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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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