The following data is part of a premarket notification filed by Goosen Enterprises, Inc. with the FDA for Acuflo, Vacuum-powered Body Fluid Suction Appara..
| Device ID | K896134 |
| 510k Number | K896134 |
| Device Name: | ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | GOOSEN ENTERPRISES, INC. P.O. BOX 10 Goldenrod, FL 32733 |
| Contact | Carl C Goosen |
| Correspondent | Carl C Goosen GOOSEN ENTERPRISES, INC. P.O. BOX 10 Goldenrod, FL 32733 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-24 |
| Decision Date | 1990-08-30 |