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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceFEMCAP
Generic NameCap, cervical, contraceptive
ApplicantFemCap, Incorporated
23290 Schoenherr
Warren, MI 48089
PMA NumberP020041
Supplement NumberS003
Date Received03/08/2013
Decision Date08/21/2013
Product Code LLQ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR KDL PRECISION MOLDING CORPORATION, A MANUFACTURING SITE LOCATED IN PACOIMA, CALIFORNIA
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