K863688 is an FDA 510(k) clearance for the ROD, IRRIGATOR, SUPPORTING TELESCOPING, TYPE. This device is classified as a Bed, Manual (Class I - General Controls, product code FNJ).
Submitted by Brenner Metal Prod Corp. (Wallington, US). The FDA issued a Cleared decision on January 20, 1987, 123 days after receiving the submission on September 19, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5120.
| 510(k) Number | K863688 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 19, 1986 |
| Decision Date | January 20, 1987 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FNJ — Bed, Manual |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5120 |