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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 K861355
Device Name WHENEVER UNSCENTED REGULAR THIN MAXI-PADS
Applicant
MARCAL PAPER MILLS, INC.
MARKET ST.
ELMWOOD PARK,  NJ  07407
Applicant Contact JOHN T BURT
Correspondent
MARCAL PAPER MILLS, INC.
MARKET ST.
ELMWOOD PARK,  NJ  07407
Correspondent Contact JOHN T BURT
Regulation Number884.5435
Classification Product Code
HHD  
Date Received04/10/1986
Decision Date 04/23/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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