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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 K914726
Device Name ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED
Applicant
Ion Laser Technology
263 Jimmy Doolittle Rd.
Salt Lake City,  UT  84116
Applicant Contact ROBERT S HEAD
Correspondent
Ion Laser Technology
263 Jimmy Doolittle Rd.
Salt Lake City,  UT  84116
Correspondent Contact ROBERT S HEAD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/21/1991
Decision Date 12/17/1991
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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