FDA 510(k) Application Details - K061526

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K061526
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SURGRX INC
101 SAGINAW DRIVE
REDWOOD CITY, CA 94063 US
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Contact LINDA OLESON
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 06/02/2006
Decision Date 06/15/2006
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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