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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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More FDA Info for this Product Code
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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