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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cup, menstrual
510(k) Number K920792
Device Name SOFTCUP(TM):2
Applicant
ULTRAFEM, INC.
1050 CONNECTICUT AVE., N.W.
WASHINGTON,  DC  20036 -5339
Applicant Contact PETER S REICHERTZ
Correspondent
ULTRAFEM, INC.
1050 CONNECTICUT AVE., N.W.
WASHINGTON,  DC  20036 -5339
Correspondent Contact PETER S REICHERTZ
Regulation Number884.5400
Classification Product Code
HHE  
Date Received02/21/1992
Decision Date 10/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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