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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K031281
Device Name ERGO SRS
Applicant
3D LINE USA, INC.
11419 CROWNRIDGE RD., STE.15
OWINGS MILLS,  MD  21117
Applicant Contact NADER SALEHI
Correspondent
3D LINE USA, INC.
11419 CROWNRIDGE RD., STE.15
OWINGS MILLS,  MD  21117
Correspondent Contact NADER SALEHI
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received04/22/2003
Decision Date 12/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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