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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 K950819
Device Name SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER)
Applicant
Surgical Laser Technologies, Inc.
200 Cresson Blvd.
P.O.Box 880
Oaks,  PA  19456
Applicant Contact RICHARD G JONES
Correspondent
Surgical Laser Technologies, Inc.
200 Cresson Blvd.
P.O.Box 880
Oaks,  PA  19456
Correspondent Contact RICHARD G JONES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/23/1995
Decision Date 04/18/1995
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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