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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, Manual
510(k) Number K890341
Device Name MICK 200-TP AND MICK TP NEEDLE
Applicant
Mick Radio-Nuclear Instruments, Inc.
P.O. Box 99
Bronx,  NY  10465
Applicant Contact FELIX W MICK
Correspondent
Mick Radio-Nuclear Instruments, Inc.
P.O. Box 99
Bronx,  NY  10465
Correspondent Contact FELIX W MICK
Regulation Number892.5650
Classification Product Code
IWJ  
Date Received01/23/1989
Decision Date 03/14/1989
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
Recalls CDRH Recalls
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