K935835 is an FDA 510(k) clearance for the BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES. This device is classified as a Tubing, Pressure And Accessories (Class I - General Controls, product code BYX).
Submitted by Busse Hospital Disposables, Inc. (Hauppauge, US). The FDA issued a Cleared decision on January 12, 1994, 36 days after receiving the submission on December 7, 1993.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5860.
| 510(k) Number | K935835 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1993 |
| Decision Date | January 12, 1994 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | BYX — Tubing, Pressure And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5860 |