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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 K091310
Device Name ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682
Applicant
Dfine, Inc.
3047 Orchard Pkwy.
San Jose,  CA  95134
Applicant Contact SANDEEP SABOO
Correspondent
Dfine, Inc.
3047 Orchard Pkwy.
San Jose,  CA  95134
Correspondent Contact SANDEEP SABOO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received05/04/2009
Decision Date 08/11/2010
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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