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FDA 510(k) Application Details - K172473
Device Classification Name
Lubricant, Patient, Vaginal, Latex Compatible
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510(K) Number
K172473
Device Name
Lubricant, Patient, Vaginal, Latex Compatible
Applicant
SXWELL USA LLC
111 Wood Avenue South, Suite 210
Iselin, NJ 08830 US
Other 510(k) Applications for this Company
Contact
Robert Mahler
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Regulation Number
884.5300
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Classification Product Code
NUC
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More FDA Info for this Product Code
Date Received
08/15/2017
Decision Date
12/15/2017
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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