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FDA 510(k) Application Details - K142304
Device Classification Name
Vibrator For Therapeutic Use, Genital
More FDA Info for this Device
510(K) Number
K142304
Device Name
Vibrator For Therapeutic Use, Genital
Applicant
REFLEXONIC, LLC
915 Toll House Avenue, Suite 205
Frederick, MD 21701 US
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Contact
Kambiz Tajkarimi
Other 510(k) Applications for this Contact
Regulation Number
884.5960
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Classification Product Code
KXQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/18/2014
Decision Date
10/03/2014
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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