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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 K062935
Device Name HABIB 4X LAPAROSCOPIC
Applicant
Rita Medical Systems
46421 Landing Pkwy.
Femont,  CA  94538
Applicant Contact DARRIN R UECKER
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131 -1230
Correspondent Contact MORTEN SIMON CHRISTENSEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/28/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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