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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tampon, Menstrual, Unscented
510(k) Number K951924
Device Name ORGANIC TAMPONS
Applicant
Eco Yarn Co.
16617 Killdeer Dr.
Rockville,  MD  20855
Applicant Contact GLENN E CONKLIN
Correspondent
Eco Yarn Co.
16617 Killdeer Dr.
Rockville,  MD  20855
Correspondent Contact GLENN E CONKLIN
Regulation Number884.5470
Classification Product Code
HEB  
Date Received04/25/1995
Decision Date 07/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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