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FDA 510(k) Application Details - K070881
Device Classification Name
Ligator, Hemorrhoidal
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510(K) Number
K070881
Device Name
Ligator, Hemorrhoidal
Applicant
SAPI MED S.P.A
1676 VILLAGE GREEN SUITE A
CROFTON, MD 21114 US
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Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
876.4400
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Classification Product Code
FHN
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More FDA Info for this Product Code
Date Received
03/30/2007
Decision Date
09/26/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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