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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K082439
Device Name DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT
Applicant
Shandong Weigao Medical Polymer Co., Ltd.
Suite 8d, # 19, Lane 999
Zhongshan # 2 Rd. (S)
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Shandong Weigao Medical Polymer Co., Ltd.
Suite 8d, # 19, Lane 999
Zhongshan # 2 Rd. (S)
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number870.1650
Classification Product Code
DXT  
Date Received08/25/2008
Decision Date 03/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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