The following data is part of a premarket notification filed by Tiger Medical Products Ltd with the FDA for Insulin Pen Needle.
| Device ID | K120690 |
| 510k Number | K120690 |
| Device Name: | INSULIN PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | TIGER MEDICAL PRODUCTS LTD 1 HUAIHAI ZHONG ROAD LIU LIN TOWER, SUITE 1910 Shanghai, CN 200021 |
| Contact | David Wang |
| Correspondent | David Wang TIGER MEDICAL PRODUCTS LTD 1 HUAIHAI ZHONG ROAD LIU LIN TOWER, SUITE 1910 Shanghai, CN 200021 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-07 |
| Decision Date | 2012-06-22 |
| Summary: | summary |