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FDA 510(k) Application Details - K093642
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K093642
Device Name
Saliva, Artificial
Applicant
INVADO PHARMACEUTICALS
25 RAVENNA DRIVE
POMONA, NY 10970 US
Other 510(k) Applications for this Company
Contact
EDWARD D KOBUS
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
11/24/2009
Decision Date
12/11/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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