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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 K923539
Device Name AMERICAN DENTAL LASER SINGLE USE CONTACT 320 HANDP
Applicant
American Dental Laser, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact CYNTHIA A SINCLAIR
Correspondent
American Dental Laser, Inc.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact CYNTHIA A SINCLAIR
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/16/1992
Decision Date 10/28/1992
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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