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FDA 510(k) Application Details - K004036
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K004036
Device Name
Condom
Applicant
EAGLE TWE, INC.
2090 TUCKER INDUSTRIAL RD.
SUITE A-5
TUCKER, GA 30084 US
Other 510(k) Applications for this Company
Contact
KEITH F HEINTZ
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
12/28/2000
Decision Date
03/27/2001
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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