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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 K972548
Device Name SLT CL MD CONTACT LASER SYSTEM
Applicant
Surgical Laser Technologies, Inc.
147 Keystone Dr.
Montgomeryville,  PA  18936
Applicant Contact MONICA FERRANTE
Correspondent
Surgical Laser Technologies, Inc.
147 Keystone Dr.
Montgomeryville,  PA  18936
Correspondent Contact MONICA FERRANTE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/08/1997
Decision Date 04/21/1998
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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