The following data is part of a premarket notification filed by Medbio Llc. with the FDA for Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel.
| Device ID | K171144 |
| 510k Number | K171144 |
| Device Name: | Medifine Pen Needle 3 Bevel, Medifine Pen Needle Quinta 5 Bevel |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Medbio LLC. 4846 Citrus Way Cooper City, FL 33330 |
| Contact | Jatin Rajani |
| Correspondent | Priscilla Chung Lk Consulting Group USA, Inc 690 Roosevelt Irvine, CA 92620 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-19 |
| Decision Date | 2017-09-12 |
| Summary: | summary |