The following data is part of a premarket notification filed by Kofu Factory Of Terumo Corp. with the FDA for Terumo Pen Injector Needle 34.
| Device ID | K140516 |
| 510k Number | K140516 |
| Device Name: | Terumo Pen Injector Needle 34 |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | KOFU FACTORY OF TERUMO CORP. 950 ELKTON BLVD Elkton, MD 21921 |
| Contact | Phillip Lester |
| Correspondent | Phillip Lester KOFU FACTORY OF TERUMO CORP. 950 ELKTON BLVD Elkton, MD 21921 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-28 |
| Decision Date | 2014-08-05 |
| Summary: | summary |