K932327 is an FDA 510(k) clearance for the THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM. This device is classified as a Bottle, Collection, Vacuum (Class II - Special Controls, product code KDQ).
Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on July 13, 1993, 61 days after receiving the submission on May 13, 1993.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K932327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1993 |
| Decision Date | July 13, 1993 |
| Days to Decision | 61 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | KDQ — Bottle, Collection, Vacuum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |