Premarket Approval (PMA)

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 Name: REALITY FEMALE CONDOM
• Classification Name: condom, female, single-use
• Regulation Number: 884.5330
• Applicant: WPC BRANDS, INC.
• PMA Number: P910064
• Supplement Number: S003
• Date Received: 07/06/1993
• Decision Date: 10/18/1994
• Product Code: MBU [ Registered Establishments with MBU ]
• Advisory Committee: Obstetrics/Gynecology
• Supplement Type: normal 180 day track
• Supplement Reason: other
• Expedited Review Granted?: No
• Combination Product: No