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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K080072
Device Name MRI PATIENT POSITIONING DEVICES
Applicant
CIVCO Medical Instruments Co., Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Applicant Contact ARTHUR WARD
Correspondent
CIVCO Medical Instruments Co., Inc.
962 Allegro Ln.
Appollo Beach,  FL  33572
Correspondent Contact ARTHUR WARD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/11/2008
Decision Date 06/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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