The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Thora-klex Chest Drainage Unit.
| Device ID | K905448 |
| 510k Number | K905448 |
| Device Name: | THORA-KLEX CHEST DRAINAGE UNIT |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Leo L Basta |
| Correspondent | Leo L Basta DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-05 |
| Decision Date | 1991-03-27 |