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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 K013300
Device Name MAXIFLEX FIBER OPTIC ENERGY DELIVERY SYSTEM
Applicant
Technology Delivery Systems, Inc.
200 Gregory Lane Suite C-100
Pleasant Hill,  CA  94523 -3389
Applicant Contact DAVID W SCHLERF
Correspondent
Technology Delivery Systems, Inc.
200 Gregory Lane Suite C-100
Pleasant Hill,  CA  94523 -3389
Correspondent Contact DAVID W SCHLERF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/03/2001
Decision Date 04/16/2002
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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