K780233 is an FDA 510(k) clearance for the TRACTION WEIGHT BAGS. This device is classified as a Apparatus, Traction, Non-powered (Class I - General Controls, product code HST).
Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 23, 1978, 14 days after receiving the submission on February 9, 1978.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.5850.
| 510(k) Number | K780233 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 09, 1978 |
| Decision Date | February 23, 1978 |
| Days to Decision | 14 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 |