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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 K933879
Device Name PADS MENSTRUAL, UNTREAT DEODORIZED, VARIOUS SIZES
Applicant
Universal Health Care Products Canada, Inc.
870 Ellingham St., Pt.e
Claire
Quebec H9r 3s4,  CA
Applicant Contact DAVE LOCKHART
Correspondent
Universal Health Care Products Canada, Inc.
870 Ellingham St., Pt.e
Claire
Quebec H9r 3s4,  CA
Correspondent Contact DAVE LOCKHART
Regulation Number884.5435
Classification Product Code
HHD  
Date Received08/09/1993
Decision Date 03/24/1994
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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