FDA 510(k) Application Details - K120247

Device Classification Name Drink, Glucose Tolerance

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510(K) Number K120247
Device Name Drink, Glucose Tolerance
Applicant VINELAND SYRUP INC.
57 HARTFORD ROAD
SEWELL, NJ 08080 US
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Contact ERIC FEERST
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Regulation Number 862.1345

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Classification Product Code MRV
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Date Received 01/27/2012
Decision Date 06/21/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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