K960937 is an FDA 510(k) clearance for the SUCTION SAFETY DEVICE. This device is classified as a Cpb Check Valve, Retrograde Flow, In-line (Class II - Special Controls, product code MJJ).
Submitted by R D Intl. (Richardson, US). The FDA issued a Cleared decision on June 5, 1996, 89 days after receiving the submission on March 8, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K960937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 08, 1996 |
| Decision Date | June 05, 1996 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MJJ — Cpb Check Valve, Retrograde Flow, In-line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |