FDA 510(k) Application Details - K073455

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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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
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Regulation Number 878.4400

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Classification Product Code GEI
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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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