The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Neurosponge Paddie.
| Device ID | K812390 |
| 510k Number | K812390 |
| Device Name: | NEUROSPONGE PADDIE |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | WINN HIRSCH & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-20 |
| Decision Date | 1981-11-24 |