The following data is part of a premarket notification filed by B. Braun Of America, Inc. with the FDA for Pencil Point Spinal Needle And Tray.
| Device ID | K932569 |
| 510k Number | K932569 |
| Device Name: | PENCIL POINT SPINAL NEEDLE AND TRAY |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Contact | Christine Harris |
| Correspondent | Christine Harris B. BRAUN OF AMERICA, INC. 824 TWELFTH AVE. PO BOX 4027 Bethlehem, PA 18018 -0027 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-27 |
| Decision Date | 1994-01-26 |