FDA 510(k) Application Details - K971040

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K971040
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant CONTOUR FABRICATORS, INC.
4100 E. BALDWIN AVE.
P.O. BOX 56
GRAND BLANC, MI 48439 US
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Contact MICHEAL CZOP
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 03/21/1997
Decision Date 04/16/1997
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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