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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Film, Radiographic
510(k) Number K844554
Device Name BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG
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 Number892.1840
Classification Product Code
IWZ  
Date Received11/21/1984
Decision Date 02/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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