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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K993400
Device Name HDR CONTOUR TP TEMPLATE AND IMPLANT ACCESSORIES
Applicant
Mick Radio-Nuclear Instruments, Inc.
1470 Outlook Ave.
P.O. Box 99
Bronx,  NY  10465
Applicant Contact FELIX MICK
Correspondent
Mick Radio-Nuclear Instruments, Inc.
1470 Outlook Ave.
P.O. Box 99
Bronx,  NY  10465
Correspondent Contact FELIX MICK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received10/08/1999
Decision Date 01/06/2000
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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