FDA 510(k) Application Details - K031371

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K031371
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SMITH & NEPHEW, INC.
3700 HAVEN COURT
MENLO PARK, CA 94025 US
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Contact LINDA GUTHRIE
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/30/2003
Decision Date 05/23/2003
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 N
Expedited Review



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