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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 K010771
Device Name PERIOLASE ND:YAG DENTAL LASER SYSTEM
Applicant
MILLENNIUM DENTAL TECHNOLOGIES, INC.
4256 HEYER AVE.
CASTRO VALLEY,  CA  94546
Applicant Contact DAVID M HARRIS
Correspondent
MILLENNIUM DENTAL TECHNOLOGIES, INC.
4256 HEYER AVE.
CASTRO VALLEY,  CA  94546
Correspondent Contact DAVID M HARRIS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/14/2001
Decision Date 11/27/2001
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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