The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac(r) A-6020--infant Single Use Chest Drai.
| Device ID | K896697 |
| 510k Number | K896697 |
| Device Name: | PLEUR-EVAC(R) A-6020--INFANT SINGLE USE CHEST DRAI |
| Classification | Bottle, Collection, Vacuum |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Harry Savard |
| Correspondent | Harry Savard DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-28 |
| Decision Date | 1990-02-08 |