The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac(r) A-8000--adult/pediatric Chest Drain.
| Device ID | K890431 |
| 510k Number | K890431 |
| Device Name: | PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-04-04 |