The following data is part of a premarket notification filed by B. Braun Melsungen Ag with the FDA for Extavipro Sterican 30g.
| Device ID | K131040 |
| 510k Number | K131040 |
| Device Name: | EXTAVIPRO STERICAN 30G |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | B. BRAUN MELSUNGEN AG BAHNSTRASSE 42-46 Friedrichsdorf, Hesse, DE 61381 |
| Contact | Karin Lubbers |
| Correspondent | Karin Lubbers B. BRAUN MELSUNGEN AG BAHNSTRASSE 42-46 Friedrichsdorf, Hesse, DE 61381 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-15 |
| Decision Date | 2013-07-15 |
| Summary: | summary |