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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K963193
Device Name ACCU-BEAM LASER BLOCK 301513BG385/BEAM SPLITTERS 301513BG39
Applicant
Transamerican Technologies Intl.
7026 Koll Center Pkwy.
Suite 207
Pleasanton,  CA  94566
Applicant Contact ALLEN R HOWES
Correspondent
Transamerican Technologies Intl.
7026 Koll Center Pkwy.
Suite 207
Pleasanton,  CA  94566
Correspondent Contact ALLEN R HOWES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/15/1996
Decision Date 11/13/1996
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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