FDA 510(k) Application Details - K030158

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K030158
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant WALSH MEDICAL DEVICES, INC.
1200 SOUTH SERVICE RD. WEST
UNIT 3
OAKVILLE, ONTARIO L6L 5T7 CA
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Contact DAVID STILES
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/16/2003
Decision Date 07/17/2003
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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