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FDA 510(k) Application Details - K170054
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
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510(K) Number
K170054
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
JACO, LLC dba Macan Manufacturing and BNA Burz North America
21 Shay Lane
Milton, DE 19968 US
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Contact
John Marsillo
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Regulation Number
878.4400
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Classification Product Code
GEI
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Date Received
01/06/2017
Decision Date
10/02/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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