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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 K902160
Device Name SABA CONFORT MENSTRUAL PAD
Applicant
Valle & Assoc.
P.O. Box 3181
Hato Rey
Puerto Rico 00919, 
Applicant Contact JOSE F VALLE
Correspondent
Valle & Assoc.
P.O. Box 3181
Hato Rey
Puerto Rico 00919, 
Correspondent Contact JOSE F VALLE
Regulation Number884.5435
Classification Product Code
HHD  
Date Received05/16/1990
Decision Date 08/21/1990
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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