FDA 510(k) Application Details - K133017

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K133017
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ESTECH, INC.
2603 CAMINO RAMON, STE 100
SAN RAMON, CA 94583 US
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Contact TAMER IBRAHIM
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 09/26/2013
Decision Date 10/07/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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