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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.
 
Trade NameREALITY FEMALE CONDOM
Classification Namecondom, female, single-use
Regulation Number884.5330
ApplicantWPC BRANDS, INC.
PMA NumberP910064
Supplement NumberS006
Date Received08/30/1993
Decision Date07/24/1995
Product Code
MBU[ Registered Establishments with MBU ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the focus group study protocol to assess patient comprehension of product labeling.
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