FDA 510(k) Application Details - K061417

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K061417
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant GENICON
6869 STAPOINT CT., SUITE 114
WINTER PARK, FL 32792 US
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Contact GARY HABERLAND
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 05/22/2006
Decision Date 10/10/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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