FDA 510(k) Application Details - K981416

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K981416
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MAGNA ADVANCED TECHNOLOGIES, INC.
7200 N.W. SEVENTH ST.
2ND FLOOR
MIAMI, FL 33126 US
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Contact ANNIE VELEZ
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/20/1998
Decision Date 06/24/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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