K960216 is an FDA 510(k) clearance for the CPR SUCTION CATHETER KIT. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Custom Pack Reliability (Orlando, US). The FDA issued a Cleared decision on April 15, 1996, 90 days after receiving the submission on January 16, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K960216 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 16, 1996 |
| Decision Date | April 15, 1996 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | JOL — Catheter And Tip, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |