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FDA 510(k) Application Details - K160644
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K160644
Device Name
Condom
Applicant
LELO Inc.
4320 Stevens Creek Blvd., Suite 205
San Jose, CA 95129 US
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Contact
Pavle Sedic
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Regulation Number
884.5300
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Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
03/07/2016
Decision Date
06/30/2016
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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