FDA 510(k) Application Details - K072937

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K072937
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant OLSEN MEDICAL
3001 WEST KENTUCKY ST.
LOUISVILLE, KY 40211 US
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Contact JOHN P WATERS
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 10/16/2007
Decision Date 12/28/2007
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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