K813052 is an FDA 510(k) clearance for the ULTRACAST WATERLESS SYNTHETIC RESIN CAST. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).
Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1982, 98 days after receiving the submission on October 29, 1981.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3025.
| 510(k) Number | K813052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 29, 1981 |
| Decision Date | February 04, 1982 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ITG — Bandage, Cast |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3025 |