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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 K812232
Device Name OBSTETRICAL PAD(STEAM STERILIZED)
Applicant
PAPER-PAK PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PAPER-PAK PRODUCTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.5435
Classification Product Code
HHD  
Date Received08/11/1981
Decision Date 08/25/1981
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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