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FDA 510(k) Application Details - K001212
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K001212
Device Name
Condom
Applicant
ARMKEL, LLC.
HALF ACRE RD.
P.O. BOX 1001
CRANBURY, NJ 08512 US
Other 510(k) Applications for this Company
Contact
STEPHEN C KOLAKOWSKY
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
04/14/2000
Decision Date
05/09/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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