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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K173646
Device Name FS Ergo
Applicant
Palodex Group OY
Nahkelantie 160
Tuusula,  FI 04300
Applicant Contact Anni Lundholm
Correspondent
Palodex Group OY
Nahkelantie 160
Tuusula,  FI 04300
Correspondent Contact Anni Lundholm
Regulation Number872.1800
Classification Product Code
MUH  
Date Received11/27/2017
Decision Date 12/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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