K820612 is an FDA 510(k) clearance for the TENSOPLAST SKIN TRACTION KIT. This device is classified as a Apparatus, Traction, Non-powered (Class I - General Controls, product code HST).
Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 31, 1982, 23 days after receiving the submission on March 8, 1982.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.5850.
| 510(k) Number | K820612 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1982 |
| Decision Date | March 31, 1982 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | HST — Apparatus, Traction, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.5850 |