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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 K854478
Device Name REI-90/90 RADIOGRAPHIC TABLE
Applicant
RADIOLOGICAL ENGINEERING, INC.
2160 LITTLETON RD.
NORTH FT. MYERS,  FL  33903
Applicant Contact RALPH FRIZZLE
Correspondent
RADIOLOGICAL ENGINEERING, INC.
2160 LITTLETON RD.
NORTH FT. MYERS,  FL  33903
Correspondent Contact RALPH FRIZZLE
Regulation Number892.1980
Classification Product Code
IXR  
Date Received11/07/1985
Decision Date 04/17/1986
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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