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FDA 510(k) Application Details - K964773
Device Classification Name
Cement, Dental
More FDA Info for this Device
510(K) Number
K964773
Device Name
Cement, Dental
Applicant
MAJESTIC DRUG CO., INC.
711-717 EAST 134TH ST.
BRONX, NY 10454 US
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Contact
LARRY FISHMAN
Other 510(k) Applications for this Contact
Regulation Number
872.3275
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Classification Product Code
EMA
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More FDA Info for this Product Code
Date Received
11/27/1996
Decision Date
02/21/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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