The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Pencan Spinal Needle.
| Device ID | K112515 |
| 510k Number | K112515 |
| Device Name: | PENCAN SPINAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Contact | Lisa Giaquinto |
| Correspondent | Lisa Giaquinto B. BRAUN MEDICAL, INC. 901 MARCON BLVD. Allentown, PA 18109 -9341 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-30 |
| Decision Date | 2011-12-22 |
| Summary: | summary |