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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 K910978
Device Name ACCU-BEAM LAPAROSCOPIC SYSTEM
Applicant
Tti Medical
7026 Koll Center Pkwy.
Suite 207
Pleasanton,  CA  94566
Applicant Contact LOWELL CROW
Correspondent
Tti Medical
7026 Koll Center Pkwy.
Suite 207
Pleasanton,  CA  94566
Correspondent Contact LOWELL CROW
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/07/1991
Decision Date 11/07/1991
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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