The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac(r) Adult/pedi Dual Coll Chest Drain Sys.
| Device ID | K924337 |
| 510k Number | K924337 |
| Device Name: | PLEUR-EVAC(R) ADULT/PEDI DUAL COLL CHEST DRAIN SYS |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Michael Santalucia |
| Correspondent | Michael Santalucia 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 | 1992-08-27 |
| Decision Date | 1993-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704410833 | K924337 | 000 |
| 14026704631282 | K924337 | 000 |
| 34026704921868 | K924337 | 000 |