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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 K983436
Device Name GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM
Applicant
Gammamed USA
2464 E. Stadium Way
Ann Arbor,  MI  48104
Applicant Contact JOHN J MUNRO III
Correspondent
Gammamed USA
2464 E. Stadium Way
Ann Arbor,  MI  48104
Correspondent Contact JOHN J MUNRO III
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/29/1998
Decision Date 10/29/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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