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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 K902271
Device Name O. B. PACK I
Applicant
Customed, Inc.
Call Box 158
Carolina Puerto Rico, 
Applicant Contact FELIX B SANTOS
Correspondent
Customed, Inc.
Call Box 158
Carolina Puerto Rico, 
Correspondent Contact FELIX B SANTOS
Regulation Number884.5435
Classification Product Code
HHD  
Date Received05/21/1990
Decision Date 08/15/1990
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
Recalls CDRH Recalls
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