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FDA 510(k) Application Details - K070915
Device Classification Name
Sigmoidoscope, Rigid, Non-Electrical
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510(K) Number
K070915
Device Name
Sigmoidoscope, Rigid, Non-Electrical
Applicant
SAPIMED S.P.A.
1676 VILLAGE GREEN, SUITE A
CROFTON, MD 21114 US
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Contact
E J SMITH
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Regulation Number
876.1500
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Classification Product Code
KDM
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More FDA Info for this Product Code
Date Received
04/02/2007
Decision Date
07/06/2007
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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