The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac Chest Drainage Systems.
| Device ID | K905768 |
| 510k Number | K905768 |
| Device Name: | PLEUR-EVAC CHEST DRAINAGE SYSTEMS |
| Classification | Bottle, Collection, Vacuum |
| 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 | KDQ |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 44026704451577 | K905768 | 000 |
| 14026704631305 | K905768 | 000 |
| 14026704631275 | K905768 | 000 |
| 14026704631251 | K905768 | 000 |
| 14026704631244 | K905768 | 000 |
| 14026704631237 | K905768 | 000 |
| 34026704631262 | K905768 | 000 |
| 34026704921882 | K905768 | 000 |
| 34026704921875 | K905768 | 000 |
| 34026704921851 | K905768 | 000 |
| 24026704921847 | K905768 | 000 |
| 24026704921823 | K905768 | 000 |
| 24026704921816 | K905768 | 000 |
| 14026704631312 | K905768 | 000 |
| 14026704631329 | K905768 | 000 |
| 14026704631336 | K905768 | 000 |
| 44026704428869 | K905768 | 000 |
| 44026704428852 | K905768 | 000 |
| 44026704428845 | K905768 | 000 |
| 44026704428821 | K905768 | 000 |
| 44026704428814 | K905768 | 000 |
| 44026704428807 | K905768 | 000 |
| 44026704428791 | K905768 | 000 |
| 44026704411120 | K905768 | 000 |
| 44026704410093 | K905768 | 000 |
| 44026704410086 | K905768 | 000 |
| 34026704631293 | K905768 | 000 |
| 14026704631343 | K905768 | 000 |
| 24026704921809 | K905768 | 000 |