K832992 is an FDA 510(k) clearance for the SOFFBAN ORTHOPEDIC PADDING. This device is classified as a Bandage, Cast (Class I - General Controls, product code ITG).
Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 14, 1983, 73 days after receiving the submission on September 2, 1983.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3025.
| 510(k) Number | K832992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1983 |
| Decision Date | November 14, 1983 |
| Days to Decision | 73 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 |