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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 K905178
Device Name DELUXE SANITARY PAD
Applicant
American Healthcare Corp.
30 Craig St.
Brantford, Ontario N3t 5m9
Canada,  CA
Applicant Contact CAROL MASON
Correspondent
American Healthcare Corp.
30 Craig St.
Brantford, Ontario N3t 5m9
Canada,  CA
Correspondent Contact CAROL MASON
Regulation Number884.5435
Classification Product Code
HHD  
Date Received11/19/1990
Decision Date 03/04/1991
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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