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FDA 510(k) Application Details - K131866
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K131866
Device Name
Condom
Applicant
HOLLENDER SUSTAINABLE BRANDS LLC
1468 HARWELL AVE
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2013
Decision Date
05/01/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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