The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Medline Epidural And Spinal Needles.
| Device ID | K110194 |
| 510k Number | K110194 |
| Device Name: | MEDLINE EPIDURAL AND SPINAL NEEDLES |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE, INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-06-17 |