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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 K912555
Device Name GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER
Applicant
Rts Technology, Inc.
35 Flagship Dr.
North Andover,  MA  01845
Applicant Contact MUNRO III
Correspondent
Rts Technology, Inc.
35 Flagship Dr.
North Andover,  MA  01845
Correspondent Contact MUNRO III
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received06/11/1991
Decision Date 08/02/1991
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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