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FDA 510(k) Application Details - K043291
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K043291
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
MEDTRONIC VASCULAR
1015 GRAMSIE RD
SHOREVIEW, MN 55126-3082 US
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Contact
DAVID D COX
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Regulation Number
878.4400
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Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
11/29/2004
Decision Date
12/21/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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