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FDA 510(k) Application Details - K990516
Device Classification Name
Calibrators, Ethyl Alcohol
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510(K) Number
K990516
Device Name
Calibrators, Ethyl Alcohol
Applicant
EMD CHEMICALS INC.
480 DEMOCRAT RD.
GIBBSTOWN, NJ 08027 US
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Contact
ANNA G BENTLEY
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Regulation Number
862.3200
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Classification Product Code
DNN
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More FDA Info for this Product Code
Date Received
02/18/1999
Decision Date
03/31/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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