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FDA 510(k) Application Details - K003867
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K003867
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
BIOFILM, INC.
3121 SCOTT ST.
VISTA, CA 92083 US
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Contact
ROBERT L DE ARMOND
Other 510(k) Applications for this Contact
Regulation Number
884.5300
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Classification Product Code
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/12/2000
Decision Date
03/09/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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