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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 K031088
Device Name TRIMED PLAN, VERSION 2.2
Applicant
TRIMED SYSTEMS, INC
1804 LOEHR ESTATES CT.
BALLWIN,  MO  63021
Applicant Contact SHERRY ZHANG
Correspondent
TRIMED SYSTEMS, INC
1804 LOEHR ESTATES CT.
BALLWIN,  MO  63021
Correspondent Contact SHERRY ZHANG
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received04/04/2003
Decision Date 07/23/2004
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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