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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 K953633
Device Name UNSCENTED MENSTRUAL PAD
Applicant
TENDASOFT, INC.
1001 VISION DR.
VAN WERT,  OH  45891
Applicant Contact DEREK DAFOE
Correspondent
TENDASOFT, INC.
1001 VISION DR.
VAN WERT,  OH  45891
Correspondent Contact DEREK DAFOE
Regulation Number884.5435
Classification Product Code
HHD  
Date Received08/04/1995
Decision Date 11/01/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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