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FDA 510(k) Application Details - K964176
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K964176
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
TECNO INSTRUMENTS (USA), INC.
P.O. BOX 991251
LOUVILLE, KY 40269 US
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Contact
MICHAEL JANOCIK
Other 510(k) Applications for this Contact
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
10/18/1996
Decision Date
08/14/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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