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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 K972709
Device Name TBI STAND
Applicant
Mick Radio-Nuclear Instruments, Inc.
1470 Outlook Ave.
P.O. Box 99
Bronx,  NY  10465
Applicant Contact FELIX W MICK
Correspondent
Mick Radio-Nuclear Instruments, Inc.
1470 Outlook Ave.
P.O. Box 99
Bronx,  NY  10465
Correspondent Contact FELIX W MICK
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/21/1997
Decision Date 10/16/1997
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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