FDA 510(k) Application Details - K992045

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K992045
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant GENESIS MEDICAL, INC.
524 WEDDEL DRIVE, SUITE 4
SUNNYVALE, CA 94089 US
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Contact THOMAS WEHMAN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/17/1999
Decision Date 01/27/2000
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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