The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Orthopedic Casting Tape Maxcast.
| Device ID | K832237 |
| 510k Number | K832237 |
| Device Name: | ORTHOPEDIC CASTING TAPE MAXCAST |
| Classification | Bandage, Cast |
| Applicant | CUTTER LABORATORIES, 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 | 1983-07-11 |
| Decision Date | 1983-08-16 |