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FDA 510(k) Application Details - K072306
Device Classification Name
Saliva, Artificial
More FDA Info for this Device
510(K) Number
K072306
Device Name
Saliva, Artificial
Applicant
BIO-X HEALTHCARE S.A.
1601 K STREET NW
WASHINGTON, DC 20036 US
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Contact
EMALEE MURPHY
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
08/17/2007
Decision Date
11/15/2007
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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