FDA 510(k) Application Details - K022718

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K022718
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant GUIDANT CORPORATION, CARDIAC SURGERY
3200 LAKESIDE DR.
SANTA CLARA, CA 95054 US
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Contact ANNE SCHLAGENHAFT
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 08/15/2002
Decision Date 08/28/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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