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FDA 510(k) Application Details - K952415
Device Classification Name
Condom With Nonoxynol-9
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510(K) Number
K952415
Device Name
Condom With Nonoxynol-9
Applicant
LONDON INTERNATIONAL U.S. HOLDINGS, INC.
1819 MAIN ST., 8TH FLOOR
P.O. BOX 4703
SARASOTA, FL 34236 US
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Contact
PHYLISS M BARBER
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Regulation Number
884.5310
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Classification Product Code
LTZ
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More FDA Info for this Product Code
Date Received
05/23/1995
Decision Date
07/15/1996
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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