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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 K101181
Device Name BEL-CAT
Applicant
Takara Belmont Corp.
8870 Ravello Court
Naples,  FL  34114
Applicant Contact DANIEL KAMM
Correspondent
Takara Belmont Corp.
8870 Ravello Court
Naples,  FL  34114
Correspondent Contact DANIEL KAMM
Regulation Number892.1750
Classification Product Code
OAS  
Date Received04/27/2010
Decision Date 07/19/2011
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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