K834361 is an FDA 510(k) clearance for the JSB JET SYRINGE. This device is classified as a Injector, Jet, Mechanical-powered (Class II - Special Controls, product code EGM).
Submitted by C.B.S. Biotechnics, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1984, 130 days after receiving the submission on October 27, 1983.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4475.
| 510(k) Number | K834361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1983 |
| Decision Date | March 05, 1984 |
| Days to Decision | 130 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EGM — Injector, Jet, Mechanical-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4475 |