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FDA 510(k) Application Details - K010371
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K010371
Device Name
Condom
Applicant
SURETEX, LTD.
1500 INDUSTRIAL RD.
P.O. BOX 1252
DOTHAN, AL 36302 US
Other 510(k) Applications for this Company
Contact
LON D MCILVAIN
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
02/07/2001
Decision Date
04/27/2001
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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