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FDA 510(k) Application Details - K024148
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K024148
Device Name
Saliva, Artificial
Applicant
SINCLAIR PHARMACEUTICALS, LTD.
BOROUGH RD.
GODALMING, SURREY GU7 2AB GB
Other 510(k) Applications for this Company
Contact
DENISE SWIFT
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/16/2002
Decision Date
09/15/2003
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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