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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 K182930
Device Name PerioLase Nd:YAG Pulsed Dental Laser System
Applicant
Millennium Dental Technologies, Inc.
10945 South Street, Suite 104-A
Cerritos,  CA  90703
Applicant Contact Robert H. Gregg
Correspondent
Millennium Dental Technologies, Inc.
10945 South Street, Suite 104-A
Cerritos,  CA  90703
Correspondent Contact Robert H. Gregg
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/22/2018
Decision Date 07/12/2019
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
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