The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac(r) A6000 Adult/pediatric Chest Drainage.
| Device ID | K881252 |
| 510k Number | K881252 |
| Device Name: | PLEUR-EVAC(R) A6000 ADULT/PEDIATRIC CHEST DRAINAGE |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Orofino |
| Correspondent | Orofino DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-23 |
| Decision Date | 1988-06-17 |