The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac-a-7000--adult/pedi Chest Drainage Syst.
| Device ID | K882223 |
| 510k Number | K882223 |
| Device Name: | PLEUR-EVAC-A-7000--ADULT/PEDI CHEST DRAINAGE SYST |
| Classification | Bottle, Collection, Vacuum |
| Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Betty Orofino |
| Correspondent | Betty Orofino DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-26 |
| Decision Date | 1988-08-16 |