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FDA 510(k) Application Details - K051812
Device Classification Name
Saliva, Artificial
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510(K) Number
K051812
Device Name
Saliva, Artificial
Applicant
LABORATOIRES CARILENE S.A.S.
1800 MASSACHUSETTS AVE., NW
WASHINGTON, DC 20036 US
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Contact
EMALEE MURPHY
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Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFD
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More FDA Info for this Product Code
Date Received
07/05/2005
Decision Date
10/21/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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