K850465 is an FDA 510(k) clearance for the CERVICAL COLLARS & HEAD HALTERS. This device is classified as a Orthosis, Cervical (Class I - General Controls, product code IQK).
Submitted by Abco Dealers, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 25, 1985, 87 days after receiving the submission on January 28, 1985.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3490.
| 510(k) Number | K850465 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1985 |
| Decision Date | April 25, 1985 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IQK — Orthosis, Cervical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3490 |