The following data is part of a premarket notification filed by Shanghai Double Dove Industrial Co., Ltd with the FDA for Sterile Blunt For Single Use.
| Device ID | K120420 |
| 510k Number | K120420 |
| Device Name: | STERILE BLUNT FOR SINGLE USE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-10 |
| Decision Date | 2012-10-18 |
| Summary: | summary |