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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 K890125
Device Name SANITARY NAPKIN PADS
Applicant
Landen Corp.
168 SE First St., Suite 709a
Miami,  FL  33131
Applicant Contact J SACASA
Correspondent
Landen Corp.
168 SE First St., Suite 709a
Miami,  FL  33131
Correspondent Contact J SACASA
Regulation Number884.5435
Classification Product Code
HHD  
Date Received01/10/1989
Decision Date 06/21/1989
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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