K923028 is an FDA 510(k) clearance for the TURKEL PNEUMOTHORAX KIT. This device is classified as a Needle, Catheter (Class I - General Controls, product code GCB).
Submitted by Symbiosis Corp. (Miami, US). The FDA issued a Cleared decision on August 4, 1992, 42 days after receiving the submission on June 23, 1992.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4200.
| 510(k) Number | K923028 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 1992 |
| Decision Date | August 04, 1992 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | GCB — Needle, Catheter |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4200 |