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FDA 510(k) Application Details - K130345
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
More FDA Info for this Device
510(K) Number
K130345
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
MAYER LABORATORIES, INC.
1950 ADDISON STREET, SUITE 101
BERKELY, CA 94704-1182 US
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Contact
DAVID P MAYER
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
NUC
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More FDA Info for this Product Code
Date Received
02/11/2013
Decision Date
08/01/2013
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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