The following data is part of a premarket notification filed by Shanghai Double Dove Industrial Co., Ltd with the FDA for Sterile Hypodermic Syringe And Needle For Single Use, Sterile Insuling Syringe For Single Use With Fixed Needle.
| Device ID | K090929 |
| 510k Number | K090929 |
| Device Name: | STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE |
| Classification | Syringe, Piston |
| Applicant | SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO. 2 ROAD (S) Shanghai, CN 200030 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-02 |
| Decision Date | 2009-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16934755702425 | K090929 | 000 |
| 16934755702227 | K090929 | 000 |
| 06934755702060 | K090929 | 000 |
| 16934755702050 | K090929 | 000 |
| 16934755702043 | K090929 | 000 |
| 16934755702036 | K090929 | 000 |
| 06934755702022 | K090929 | 000 |
| 06934755702008 | K090929 | 000 |