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FDA 510(k) Application Details - K963763
Device Classification Name
Electrode, Ion Specific, Sodium
More FDA Info for this Device
510(K) Number
K963763
Device Name
Electrode, Ion Specific, Sodium
Applicant
MEDICA CORP.
14 DEANGELO DR.
BEDFORD, MA 01730 US
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Contact
Photios Makris
Other 510(k) Applications for this Contact
Regulation Number
862.1665
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Classification Product Code
JGS
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More FDA Info for this Product Code
Date Received
09/19/1996
Decision Date
11/29/1996
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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