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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, Intraoral
510(k) Number K900681
Device Name PANORAMIC MODEL X-CALIBER X-RAY
Applicant
Belmont Equipment Corp.
One Belmont Dr.
Somerset,  NJ  08873
Applicant Contact JOHN M GARDELLA
Correspondent
Belmont Equipment Corp.
One Belmont Dr.
Somerset,  NJ  08873
Correspondent Contact JOHN M GARDELLA
Regulation Number872.1810
Classification Product Code
EAP  
Date Received02/12/1990
Decision Date 05/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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