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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 K895733
Device Name FIBERVISION(TM)
Applicant
Fiber Imaging, Inc.
520 N. Skinker
St. Louis,  MO  63130
Applicant Contact ROBERT M JOHNSON
Correspondent
Fiber Imaging, Inc.
520 N. Skinker
St. Louis,  MO  63130
Correspondent Contact ROBERT M JOHNSON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/26/1989
Decision Date 11/21/1989
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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