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FDA 510(k) Application Details - K955183
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K955183
Device Name
Condom
Applicant
L & N CORP.
83 AMES ST.
BROCKTON, MA 02402 US
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Contact
DAN NGUYEN
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
11/13/1995
Decision Date
02/11/1997
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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