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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K090873
Device Name I OPEN 0.5T
Applicant
Beijing Wandong Medical Equipment Co., Ltd.
# 7, Sanjianfang Nanli
Chao Yang District, Beijing,  CN 100024
Applicant Contact WANG WEIMIN
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.1000
Classification Product Code
LNH  
Date Received03/31/2009
Decision Date 04/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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