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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K904753
Device Name DIOLASE
Applicant
Scanditronix, Inc.
Husbyborg, S-752 29
Uppsala
Sweden,  SE
Applicant Contact LENNART WARD
Correspondent
Scanditronix, Inc.
Husbyborg, S-752 29
Uppsala
Sweden,  SE
Correspondent Contact LENNART WARD
Regulation Number892.5780
Classification Product Code
IWE  
Date Received10/19/1990
Decision Date 11/09/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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