FDA 510(k) Application Details - K103840

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K103840
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant FLEXBAR MACHINE CORP.
30 NORTHPORT ROAD
SOUND BEACH, NY 11764 US
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Contact STEPHEN T MLCOCH
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 12/10/2010
Decision Date 02/28/2011
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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