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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 K924175
Device Name SABA CONFORT
Applicant
SCOTT PAPER CO.
SCOTT PLAZA I
PHILADELPHIA,  PA  19113
Applicant Contact BARBARA KRETCHMAR
Correspondent
SCOTT PAPER CO.
SCOTT PLAZA I
PHILADELPHIA,  PA  19113
Correspondent Contact BARBARA KRETCHMAR
Regulation Number884.5435
Classification Product Code
HHD  
Date Received08/19/1992
Decision Date 12/23/1993
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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