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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, Extraoral Source, Digital
510(k) Number K110160
Device Name BEL-CYPHER N
Applicant
Takara Belmont Corporation
101 Belmont Dr.
Somerset,  NJ  08873
Applicant Contact KUNIHIKO SOBUE
Correspondent
Takara Belmont Corporation
101 Belmont Dr.
Somerset,  NJ  08873
Correspondent Contact KUNIHIKO SOBUE
Regulation Number872.1800
Classification Product Code
MUH  
Date Received01/19/2011
Decision Date 02/17/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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