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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K083687
Device Name BAIXIN INTRAVASCULAR ADMINISTRATION SET
Applicant
Anhui Kangda Medical Products Co., Ltd.
1707 Yinqiao Bldg.
58 Jinxin Rd., Jinqiao
Pudong, Shanghai,  CN 201206
Applicant Contact BIAN WEI QIANG
Correspondent
Anhui Kangda Medical Products Co., Ltd.
1707 Yinqiao Bldg.
58 Jinxin Rd., Jinqiao
Pudong, Shanghai,  CN 201206
Correspondent Contact BIAN WEI QIANG
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/12/2008
Decision Date 06/11/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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