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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 K834279
Device Name ACURAY 071A DENTAL INTRAORAL X-RAY
Applicant
Belmont Equipment Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Belmont Equipment Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.1810
Classification Product Code
EAP  
Date Received11/22/1983
Decision Date 12/29/1983
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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