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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 K943638
Device Name USDL MODEL SELECT 1000 FREQUENCY DOUBLED ND:YAG LASER SYSTEM
Applicant
United States Dental Laser, Inc.
P.O. Box 6796
Suite F-13, Village At Wexford
Hilton Head Island,  SC  29938
Applicant Contact KENNETH KOWALYK, DMD
Correspondent
United States Dental Laser, Inc.
P.O. Box 6796
Suite F-13, Village At Wexford
Hilton Head Island,  SC  29938
Correspondent Contact KENNETH KOWALYK, DMD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/27/1994
Decision Date 03/06/1995
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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