The following data is part of a premarket notification filed by American Medical Disposable, Inc. with the FDA for Non Wetting Undercast Padding.
| Device ID | K833732 |
| 510k Number | K833732 |
| Device Name: | NON WETTING UNDERCAST PADDING |
| Classification | Bandage, Cast |
| Applicant | AMERICAN MEDICAL DISPOSABLE, INC. 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 | 1983-10-25 |
| Decision Date | 1983-12-12 |