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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K081241
Device Name WEIGAO EMPTY CARTRIDGE SYRINGE
Applicant
Shandong Weigao Group Medical Polymer Co., Ltd.
Suite 8d, # 19, Ln. 999
Zhongshan # 2 Rd. (S)
Shanghai,  CN 200030
Applicant Contact Diana Hong
Correspondent
Shandong Weigao Group Medical Polymer Co., Ltd.
Suite 8d, # 19, Ln. 999
Zhongshan # 2 Rd. (S)
Shanghai,  CN 200030
Correspondent Contact Diana Hong
Regulation Number880.5860
Classification Product Code
FMF  
Date Received05/01/2008
Decision Date 09/08/2008
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
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