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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K141293
Device Name PHOT-X IIS MODEL 505
Applicant
Takara Belmont Corporation
1120 Bloomfiled Ave.
West Caldwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Takara Belmont Corporation
1120 Bloomfiled Ave.
West Caldwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number872.1800
Classification Product Code
EHD  
Date Received05/19/2014
Decision Date 09/03/2014
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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