The following data is part of a premarket notification filed by Isopedix Corp. with the FDA for Support Products Example Proset Cast.
| Device ID | K830650 |
| 510k Number | K830650 |
| Device Name: | SUPPORT PRODUCTS EXAMPLE PROSET CAST |
| Classification | Bandage, Cast |
| Applicant | ISOPEDIX CORP. 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 | 1983-03-03 |
| Decision Date | 1983-07-07 |