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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, radiation therapy, radionuclide
510(k) Number K973441
Device Name LEKSELL GAMMAPLAN
Applicant
PATTERSON CONSULTING GROUP, INC.
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Applicant Contact CAROL PATTERSON
Correspondent
PATTERSON CONSULTING GROUP, INC.
18140 SMOKESIGNAL DR.
SAN DIEGO,  CA  92127
Correspondent Contact CAROL PATTERSON
Regulation Number892.5750
Classification Product Code
IWB  
Date Received09/11/1997
Decision Date 04/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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