The following data is part of a premarket notification filed by Ballard Medical Products with the FDA for Lutz Needle.
| Device ID | K013892 |
| 510k Number | K013892 |
| Device Name: | LUTZ NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Contact | Sydnee F Mcmillan |
| Correspondent | Sydnee F Mcmillan BALLARD MEDICAL PRODUCTS 12050 LONE PEAK PKWY. Draper, UT 84020 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-07-11 |
| Summary: | summary |