The following data is part of a premarket notification filed by Medibio Usa Llc. with the FDA for Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel.
| Device ID | K180720 |
| 510k Number | K180720 |
| Device Name: | Medifine Pen Needle 3 Bevel; Medifine Pen Needle Quinta 5 Bevel |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Medibio Usa 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 | 2018-03-19 |
| Decision Date | 2018-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10036800234502 | K180720 | 000 |
| 10021292015005 | K180720 | 000 |
| 10311917136322 | K180720 | 000 |
| 10311917136339 | K180720 | 000 |
| 10311917136346 | K180720 | 000 |
| 10050428646066 | K180720 | 000 |
| 10050428647551 | K180720 | 000 |
| 10021292014756 | K180720 | 000 |
| 10021292014763 | K180720 | 000 |
| 10021292014770 | K180720 | 000 |
| 10021292014787 | K180720 | 000 |
| 10021292014992 | K180720 | 000 |