FDA 510(k) Application Details - K970039

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K970039
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MEDTREX, INC.
9712 S. ALTAMONT DR.
SANDY, UT 84092 US
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Contact WILLIAM E MCKAY
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/06/1997
Decision Date 02/26/1997
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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