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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 K983478
Device Name ORGANIC ESSENTIALS, ORGANIC COTTON TAMPON
Applicant
Organic Essentials
822 Baldridge St.
O'Donnell,  TX  79351
Applicant Contact LA RHEA PEPPER
Correspondent
Organic Essentials
822 Baldridge St.
O'Donnell,  TX  79351
Correspondent Contact LA RHEA PEPPER
Regulation Number884.5470
Classification Product Code
HEB  
Date Received10/02/1998
Decision Date 11/09/1998
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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