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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 K965180
Device Name STRAIGHTFIRE REUSABLE OPTICAL FIBERS (400,600,800,1000)
Applicant
Myriad Lase, Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Applicant Contact RICHARD A HAMER
Correspondent
Myriad Lase, Inc.
100 E. 15th St.,Suite 320
Fort Worth,  TX  76102
Correspondent Contact RICHARD A HAMER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/24/1996
Decision Date 06/05/1997
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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