K870100 is an FDA 510(k) clearance for the PLASTER STAND. This device is classified as a Instrument, Cast Application/removal, Manual (Class I - General Controls, product code LGG).
Submitted by Orthopedic Systems, Inc. (Hayward, US). The FDA issued a Cleared decision on January 28, 1987, 19 days after receiving the submission on January 9, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.5980.
| 510(k) Number | K870100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 09, 1987 |
| Decision Date | January 28, 1987 |
| Days to Decision | 19 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 |