The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Omnican Fine.
| Device ID | K173803 |
| 510k Number | K173803 |
| Device Name: | Omnican Fine |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Contact | Kimberly Smith |
| Correspondent | Kimberly Smith B. Braun Medical Inc. 901 Marcon Blvd. Allentown, PA 18109 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-15 |
| Decision Date | 2018-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04046955064434 | K173803 | 000 |
| 04046955064403 | K173803 | 000 |
| 04046955064373 | K173803 | 000 |
| 04046955064342 | K173803 | 000 |
| 04046955138043 | K173803 | 000 |