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FDA 510(k) Application Details - K013086
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K013086
Device Name
Condom
Applicant
TRIGG LABORATORIES, INC.
WARNER CENTER PLAZA
21800 OXNARD STREET, SUITE 840
WOODLAND HILLS, CA 91367 US
Other 510(k) Applications for this Company
Contact
W. PATRICK NOONAN
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
09/14/2001
Decision Date
12/13/2001
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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