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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K934398
Device Name ACCU-BEAM TISSUE DRILL & ASPIRATION/INJECTION NEEDLE
Applicant
Transamerican Technologies Intl.
7026 Koll Center Pkwy.
Suite 207
Pleasanton,  CA  94566
Applicant Contact LOWELL CROW
Correspondent
Transamerican Technologies Intl.
7026 Koll Center Pkwy.
Suite 207
Pleasanton,  CA  94566
Correspondent Contact LOWELL CROW
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/08/1993
Decision Date 02/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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