K801701 is an FDA 510(k) clearance for the BAUER & BLACK RIGID WRIST BRACE. This device is classified as a Orthosis, Limb Brace (Class I - General Controls, product code IQI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 7, 1980, 14 days after receiving the submission on July 24, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3475.
| 510(k) Number | K801701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 1980 |
| Decision Date | August 07, 1980 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQI — Orthosis, Limb Brace |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3475 |