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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceREALITY FEMALE CONDOM
Classification Namecondom, female, single-use
Generic Namecondom, female, single-use
Applicant
THE FEMALE HEALTH CO.
515 north state st.
suite 2225
chicago, IL 60654
PMA NumberP910064
Supplement NumberS009
Date Received01/18/1994
Decision Date07/24/1995
Product Code
MBU[ Registered Establishments with MBU ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Additional data provided on the in vitro barrier properties of the device with respect to sexually transmitted diseases. These data were provided in satisfaction of the conditions of approval contained in fda's may 7, 1993 letter.
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