K770898 is an FDA 510(k) clearance for the FRACTURE CAST BRACE KIT, PLASTIC. This device is classified as a Splint, Traction (Class I - General Controls, product code HSP).
Submitted by Chase Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977, 66 days after receiving the submission on May 16, 1977.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.5890.
| 510(k) Number | K770898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 1977 |
| Decision Date | July 21, 1977 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | HSP — Splint, Traction |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.5890 |