The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Thora-klex 350 Ml Pediatric Chest Drainage System.
| Device ID | K932327 |
| 510k Number | K932327 |
| Device Name: | THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM |
| Classification | Bottle, Collection, Vacuum |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-13 |
| Decision Date | 1993-07-13 |