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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 K984486
Device Name PULSEMASTER DENTAL LASER SYSTEM
Applicant
American Dental Technologies, Inc.
18860 W. Ten Mile Rd.
Southfield,  MI  48075
Applicant Contact JOHN G SULEWSKI
Correspondent
American Dental Technologies, Inc.
18860 W. Ten Mile Rd.
Southfield,  MI  48075
Correspondent Contact JOHN G SULEWSKI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/17/1998
Decision Date 05/13/1999
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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