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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 K922591
Device Name UROLOGICAL C-ARM TABLE, MODEL #056-450
Applicant
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Applicant Contact CLYDE SCHEIN
Correspondent
Biodan Medical Systems, Ltd.
Brookhave R & D Plz.
20 Ramsay Rd.,Box 702
Shirley,  NY  11967
Correspondent Contact CLYDE SCHEIN
Regulation Number892.1980
Classification Product Code
IXR  
Date Received06/02/1992
Decision Date 11/27/1992
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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