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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K130443
Device Name I-MAX TOUCH 3D
Applicant
Owandy
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact Claude Berthoin
Correspondent
Owandy
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact Claude Berthoin
Regulation Number892.1750
Classification Product Code
OAS  
Date Received02/21/2013
Decision Date 06/14/2013
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
Recalls CDRH Recalls
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