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FDA 510(k) Application Details - K200114
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K200114
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
BioFilm Inc
3225 Executive Ridge
Vista, CA 92081 US
Other 510(k) Applications for this Company
Contact
Richard Hines
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/21/2020
Decision Date
10/13/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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