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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K213479
Device Name D²RS and D²RS 9090
Applicant
Stephanix
10, Rue Jean Moulin Z.I Du Bayon
La Ricamarie,  FR 42150
Applicant Contact Sandie Perret
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received10/29/2021
Decision Date 12/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
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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