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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 K871933
Device Name MODEL 5050 SURGILASER FOR NEUROSURGERY USE
Applicant
Lasermatic, Inc.
P.O. Box 7848
Dallas,  TX  75209
Applicant Contact DONALD F HULTS
Correspondent
Lasermatic, Inc.
P.O. Box 7848
Dallas,  TX  75209
Correspondent Contact DONALD F HULTS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/19/1987
Decision Date 01/22/1988
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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