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FDA 510(k) Application Details - K073455
Device Classification Name
Electrosurgical, Cutting & Coagulation & Accessories
More FDA Info for this Device
510(K) Number
K073455
Device Name
Electrosurgical, Cutting & Coagulation & Accessories
Applicant
NEW LEAF MEDICAL, INC.
11476 HAWKE RD
SUITE #C
COLUMBIA STATION, OH 44028 US
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Contact
RICHARD T NOCK
Other 510(k) Applications for this Contact
Regulation Number
878.4400
More FDA Info for this Regulation Number
Classification Product Code
GEI
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More FDA Info for this Product Code
Date Received
12/10/2007
Decision Date
03/25/2008
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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