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FDA 510(k) Application Details - K070800
Device Classification Name
Condom, Synthetic
More FDA Info for this Device
510(K) Number
K070800
Device Name
Condom, Synthetic
Applicant
ANSELL HEALTHCARE PRODUCTS LLC
1635 INDUSTRIAL RD.
DOTHAN, AL 36303 US
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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
MOL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/23/2007
Decision Date
03/06/2008
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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