K841970 is an FDA 510(k) clearance for the CAMELBACK HANDLE-K841969-LABELING. This device is classified as a Orthopedic Manual Surgical Instrument (Class I - General Controls, product code LXH).
Submitted by Stainless Mfg., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 19, 1984, 36 days after receiving the submission on May 14, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4540.
| 510(k) Number | K841970 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1984 |
| Decision Date | June 19, 1984 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LXH — Orthopedic Manual Surgical Instrument |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.4540 |