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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 K031819
Device Name DIO-DENT 10 DENTAL DIODE LASER
Applicant
Msq (M2) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact ARAVA HACOHEN
Correspondent
Msq (M2) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact ARAVA HACOHEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/12/2003
Decision Date 10/30/2003
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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