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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 K872287
Device Name LADY FREE UNSCENTED MENSTRUAL PAD
Applicant
American Tissue Corp.
3 Duplainville Rd.
Saratoga Springs,  NY  12866
Applicant Contact STEVEN C CATALFAMO
Correspondent
American Tissue Corp.
3 Duplainville Rd.
Saratoga Springs,  NY  12866
Correspondent Contact STEVEN C CATALFAMO
Regulation Number884.5435
Classification Product Code
HHD  
Date Received06/16/1987
Decision Date 08/05/1987
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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