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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 K122840
Device Name CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407
Applicant
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Ave.
Mt. Vernon,  NY  10550
Applicant Contact CHUCK SMITH
Correspondent
Mick Radio-Nuclear Instruments, Inc.
521 Homestead Ave.
Mt. Vernon,  NY  10550
Correspondent Contact CHUCK SMITH
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/17/2012
Decision Date 12/14/2012
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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