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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 K875309
Device Name SANITARY MENSTRUAL NAPKIN
Applicant
Universal Health Care Products Canada, Inc.
870 Ellingham St., Pt.e
Claire
Quebec H9r 3s4,  CA
Applicant Contact GLENN AWADA
Correspondent
Universal Health Care Products Canada, Inc.
870 Ellingham St., Pt.e
Claire
Quebec H9r 3s4,  CA
Correspondent Contact GLENN AWADA
Regulation Number884.5435
Classification Product Code
HHD  
Date Received12/29/1987
Decision Date 03/14/1988
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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