K834384 is an FDA 510(k) clearance for the MODULAR EXTREMITY CASTING SUPPORT. This device is classified as a Instrument, Cast Application/removal, Manual (Class I - General Controls, product code LGG).
Submitted by Buckman Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 30, 1984, 47 days after receiving the submission on December 14, 1983.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.5980.
| 510(k) Number | K834384 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 14, 1983 |
| Decision Date | January 30, 1984 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | LGG — Instrument, Cast Application/removal, Manual |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.5980 |