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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 K970108
Device Name HARMONIES MENSTRUAL TAMPON
Applicant
ECOPROGRESS INTL.
9055 HUNTCLIFF TRACE
ATLANTA,  GA  30350
Applicant Contact LARRY C SHATTLES
Correspondent
ECOPROGRESS INTL.
9055 HUNTCLIFF TRACE
ATLANTA,  GA  30350
Correspondent Contact LARRY C SHATTLES
Regulation Number884.5470
Classification Product Code
HEB  
Date Received01/13/1997
Decision Date 04/03/1997
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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