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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Radiographic, Non-Tilting, Powered
510(k) Number K761339
Device Name RADIAL TRAVEL SPEC. PROCEDURES TABLE
Applicant
Xre Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Xre Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number892.1980
Classification Product Code
IZZ  
Date Received12/27/1976
Decision Date 01/05/1977
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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