FDA 510(k) Application Details - K970108

Device Classification Name Tampon, Menstrual, Unscented

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510(K) Number K970108
Device Name Tampon, Menstrual, Unscented
Applicant ECOPROGRESS INTL.
9055 HUNTCLIFF TRACE
ATLANTA, GA 30350 US
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Contact LARRY C SHATTLES
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Regulation Number 884.5470

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Classification Product Code HEB
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Date Received 01/13/1997
Decision Date 04/03/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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