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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 K040704
Device Name MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR
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 Received03/18/2004
Decision Date 06/18/2004
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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