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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 K002269
Device Name ELECTROSURGICAL PROBES AND DEVICES-GELTX
Applicant
Ximed/Prosure/Injectx
2193 Trade Zone Blvd.
San Jose,  CA  95131
Applicant Contact ASHVIN DESAI
Correspondent
Ximed/Prosure/Injectx
2193 Trade Zone Blvd.
San Jose,  CA  95131
Correspondent Contact ASHVIN DESAI
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
FAS  
Date Received07/26/2000
Decision Date 01/04/2001
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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