FDA 510(k) Application Details - K120416

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K120416
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SPECTRUM SURGICAL SUPPLY CORP.
4575 HUDSON DR.
STOW, OH 44224 US
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Contact DENNIS A KOVIT
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 02/10/2012
Decision Date 03/27/2012
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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