The following data is part of a premarket notification filed by Shandong Weigao Medical Polymer Co., Ltd with the FDA for 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.
Device ID | K082439 |
510k 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 |
Classification | Injector And Syringe, Angiographic |
Applicant | SHANDONG WEIGAO MEDICAL POLYMER CO., LTD SUITE 8D, NO.19, LANE 999, ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
Contact | Diana Hong |
Correspondent | Diana Hong SHANDONG WEIGAO MEDICAL POLYMER CO., LTD SUITE 8D, NO.19, LANE 999, ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
Product Code | DXT |
CFR Regulation Number | 870.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-08-25 |
Decision Date | 2009-03-23 |
Summary: | summary |