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FDA 510(k) Application Details - K980953
Device Classification Name
Mouthguard, Prescription
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510(K) Number
K980953
Device Name
Mouthguard, Prescription
Applicant
JEROME M. SIMON
1500 SUMMER ST.
STAMFORD, CT 06905 US
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JEROME M SIMON
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Regulation Number
000.0000
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Classification Product Code
MQC
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More FDA Info for this Product Code
Date Received
03/13/1998
Decision Date
10/07/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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