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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, Tilting
510(k) Number K853175
Device Name REI-90/15
Applicant
Radiological Engineering, Inc.
2160 Littleton Rd.
North Ft. Myers,  FL  33903
Applicant Contact RALPH L FRIZZLE
Correspondent
Radiological Engineering, Inc.
2160 Littleton Rd.
North Ft. Myers,  FL  33903
Correspondent Contact RALPH L FRIZZLE
Regulation Number892.1980
Classification Product Code
IXR  
Date Received07/30/1985
Decision Date 10/10/1985
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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