The following data is part of a premarket notification filed by Iberhospitex, S.a. with the FDA for Drenovac.
| Device ID | K883982 |
| 510k Number | K883982 |
| Device Name: | DRENOVAC |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | IBERHOSPITEX, S.A. AVENIDA DE CATALUNYA, NO. 4 08185 LLISSA DE VALL Barcelona, Spain, ES |
| Contact | Lopez Rodriguez |
| Correspondent | Lopez Rodriguez IBERHOSPITEX, S.A. AVENIDA DE CATALUNYA, NO. 4 08185 LLISSA DE VALL Barcelona, Spain, ES |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1989-02-23 |