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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K030158
Device Name UNIT, CAUTERY, TEHRMAL,BATTERY-POWERED
Applicant
Walsh Medical Devices, Inc.
1200 S. Service Rd. W.
Unit 3
Oakville, Ontario,  CA L6L 5T7
Applicant Contact DAVID STILES
Correspondent
Walsh Medical Devices, Inc.
1200 S. Service Rd. W.
Unit 3
Oakville, Ontario,  CA L6L 5T7
Correspondent Contact DAVID STILES
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HQR  
Date Received01/16/2003
Decision Date 07/17/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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