The following data is part of a premarket notification filed by Hexcel Medical with the FDA for Urethane Orthopaedic Casting Tape.
| Device ID | K811164 |
| 510k Number | K811164 |
| Device Name: | URETHANE ORTHOPAEDIC CASTING TAPE |
| Classification | Bandage, Cast |
| Applicant | HEXCEL MEDICAL 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 | 1981-04-28 |
| Decision Date | 1981-05-27 |