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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 K980395
Device Name GLADRAGS COTTON MENSTRUAL PAD
Applicant
Keepers!, Inc.
2110 N. Williams
P O Box 12648
Portland,  OR  97212
Applicant Contact BRENDA MALLORY
Correspondent
Keepers!, Inc.
2110 N. Williams
P O Box 12648
Portland,  OR  97212
Correspondent Contact BRENDA MALLORY
Regulation Number884.5435
Classification Product Code
HHD  
Date Received02/02/1998
Decision Date 04/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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