The following data is part of a premarket notification filed by B.braun Medical, Inc with the FDA for Perican Ultra.
| Device ID | K133632 |
| 510k Number | K133632 |
| Device Name: | PERICAN ULTRA |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | B.BRAUN MEDICAL, INC 901 MARCON BLVD Allentown, PA 18109 -4962 |
| Contact | Lisa Giaquinto |
| Correspondent | Lisa Giaquinto B.BRAUN MEDICAL, INC 901 MARCON BLVD Allentown, PA 18109 -4962 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2014-06-27 |
| Summary: | summary |