The following data is part of a premarket notification filed by Winn Hirsch & Assoc. with the FDA for Cotton Under Cast Padding.
| Device ID | K800195 |
| 510k Number | K800195 |
| Device Name: | COTTON UNDER CAST PADDING |
| Classification | Bandage, Cast |
| Applicant | WINN HIRSCH & ASSOC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ITG |
| CFR Regulation Number | 890.3025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-01-29 |
| Decision Date | 1980-02-11 |