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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pad, Menstrual, Unscented
510(k) Number K922911
Device Name OPTIONS COMFORT CURVES CLOTH MENSTRUAL PAD SYSTEM
Applicant
Feminine Options
1898 Upper Afton Rd.
St. Paul,  MN  55119
Applicant Contact GAYLE ADAMS
Correspondent
Feminine Options
1898 Upper Afton Rd.
St. Paul,  MN  55119
Correspondent Contact GAYLE ADAMS
Regulation Number884.5435
Classification Product Code
HHD  
Date Received06/17/1992
Decision Date 04/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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