FDA 510(k) Application Details - K043198

Device Classification Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed

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510(K) Number K043198
Device Name Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
Applicant VANGUARD MEDICAL CONCEPTS, INC.
5307 GREAT OAK DR.
LAKELAND, FL 33815 US
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Contact HEATHER CRAWFORD
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Regulation Number 878.4400

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Classification Product Code NUJ
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Date Received 11/18/2004
Decision Date 05/27/2005
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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