The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Pleur-evac A-8002--adult/pediatric Dual Collection.
| Device ID | K892915 |
| 510k Number | K892915 |
| Device Name: | PLEUR-EVAC A-8002--ADULT/PEDIATRIC DUAL COLLECTION |
| 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 | 1989-04-20 |
| Decision Date | 1989-06-21 |