K760003 is an FDA 510(k) clearance for the CAST MATERIAL (WICKET STOCKINETTE). 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 July 26, 1976, 61 days after receiving the submission on May 26, 1976.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3025.
| 510(k) Number | K760003 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1976 |
| Decision Date | July 26, 1976 |
| Days to Decision | 61 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 |