FDA 510(k) Application Details - K960298

Device Classification Name Clinical Sample Concentrator

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510(K) Number K960298
Device Name Clinical Sample Concentrator
Applicant VIVASCIENCE, INC.
P.O. BOX 2240
ACTON, MA 01720 US
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Contact DENIS B HUNT
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Regulation Number 862.2310

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Classification Product Code JJH
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Date Received 01/22/1996
Decision Date 03/19/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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