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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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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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