K803212 is an FDA 510(k) clearance for the BAUER & BLACK ARM SLING W/DETACH. POUCH. This device is classified as a Sling, Arm (Class I - General Controls, product code ILI).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 8, 1981, 22 days after receiving the submission on December 17, 1980.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3640.
| 510(k) Number | K803212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 1980 |
| Decision Date | January 08, 1981 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILI — Sling, Arm |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3640 |