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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 K090893
Device Name TIGRT TPS
Applicant
LINATECH, LLC
1294 KIFER ROAD
# 705
SUNNYVALE,  CA  94086
Applicant Contact JONATHAN YAO
Correspondent
LINATECH, LLC
1294 KIFER ROAD
# 705
SUNNYVALE,  CA  94086
Correspondent Contact JONATHAN YAO
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/31/2009
Decision Date 07/15/2009
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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