K904120 is an FDA 510(k) clearance for the ACCU-FLO* UNITIZED SHUNT. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on October 9, 1990, 33 days after receiving the submission on September 6, 1990.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K904120 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1990 |
| Decision Date | October 09, 1990 |
| Days to Decision | 33 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | JXG - Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |