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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 K940377
Device Name UNSCENTED MENSTRUAL PAD TIER-1 REVIEW
Applicant
ELDARI, LTD.
1615 L STREET, N.W.
WASHINGTON,  DC  20036
Applicant Contact NANCY L BUC
Correspondent
ELDARI, LTD.
1615 L STREET, N.W.
WASHINGTON,  DC  20036
Correspondent Contact NANCY L BUC
Regulation Number884.5435
Classification Product Code
HHD  
Date Received01/26/1994
Decision Date 03/25/1994
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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