FDA 510(k) Application Details - K040104

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K040104
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE, CA 95134 US
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Contact APRIL I MALMBORG
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/20/2004
Decision Date 02/18/2004
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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