The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Neuro Sponge.
| Device ID | K140369 |
| 510k Number | K140369 |
| Device Name: | MEDLINE NEURO SPONGE |
| Classification | Neurosurgical Paddie |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60006 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60006 |
| Product Code | HBA |
| CFR Regulation Number | 882.4700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-14 |
| Decision Date | 2014-09-26 |