FDA 510(k) Application Details - K024266

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K024266
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant MEDSPHERE INTERNATIONAL, INC
48511 WARM SPRINGS BLVD.
SUITE 212
FREMONT, CA 94539 US
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Contact ERIC KAO
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 12/23/2002
Decision Date 03/12/2003
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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