The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac(r) A-7002--adult/pediatric Drainage.
| Device ID | K884844 |
| 510k Number | K884844 |
| Device Name: | PLEUR-EVAC(R) A-7002--ADULT/PEDIATRIC DRAINAGE |
| Classification | Apparatus, Autotransfusion |
| Applicant | DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Contact | Ronald Duchene |
| Correspondent | Ronald Duchene DEKNATEL, INC. KILOMETER 9 CARRETERA San Jose-heredia, CR |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-21 |
| Decision Date | 1989-01-24 |