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FDA 510(k) Application Details - K960298
Device Classification Name
Clinical Sample Concentrator
More FDA Info for this Device
510(K) Number
K960298
Device Name
Clinical Sample Concentrator
Applicant
VIVASCIENCE, INC.
P.O. BOX 2240
ACTON, MA 01720 US
Other 510(k) Applications for this Company
Contact
DENIS B HUNT
Other 510(k) Applications for this Contact
Regulation Number
862.2310
More FDA Info for this Regulation Number
Classification Product Code
JJH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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