K832991 is an FDA 510(k) clearance for the HYPAL ADHESIVE TAPE. This device is classified as a Goniometer, Ac-powered (Class I - General Controls, product code KQX).
Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984, 150 days after receiving the submission on September 2, 1983.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.
| 510(k) Number | K832991 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1983 |
| Decision Date | January 30, 1984 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | KQX — Goniometer, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.1500 |