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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, Mobile
510(k) Number K173018
Device Name MDR17 Mobile Direct Radiographic System
Applicant
Del Medical, Inc.
241 Covington Dr.
Bloomingdale,  IL  60108
Applicant Contact Tony Bavuso
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1720
Classification Product Code
IZL  
Date Received09/28/2017
Decision Date 11/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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