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FDA 510(k) Application Details - K062653
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K062653
Device Name
Saliva, Artificial
Applicant
PARNELL PHARMACEUTICALS, INC.
1525 FRANCISCO BLVD., STE. 15
SAN RAFAEL, CA 94901 US
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Contact
FRANCIS W PARNELL
Other 510(k) Applications for this Contact
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
09/07/2006
Decision Date
10/27/2006
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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