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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 K943014
Device Name BALLOON ELECTROSURGICAL PROBES AND DEVICES
Applicant
Ximed Medical Systems
2196 Trade Zone Blvd.
San Jose,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
Ximed Medical Systems
2196 Trade Zone Blvd.
San Jose,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/24/1994
Decision Date 03/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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