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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 K011657
Device Name HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR
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 Received05/29/2001
Decision Date 08/27/2001
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
Recalls CDRH Recalls
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