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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 EAST STADIUM WAY
ANN ARBOR,  MI  48104
Applicant Contact JOHN J MUNRO III
Correspondent
GAMMAMED USA
2464 EAST 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
Recalls CDRH Recalls
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