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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 K033828
Device Name CT COMPATIBLE INTRAUTERINE SLEEVES, CAT #0311, 9406
Applicant
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Ave.
Mt. Vernon,  NY  10550
Applicant Contact FELIX MICK
Correspondent
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Ave.
Mt. Vernon,  NY  10550
Correspondent Contact FELIX MICK
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received12/10/2003
Decision Date 02/02/2004
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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