The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Fluid Drainage Tray.
| Device ID | K926109 |
| 510k Number | K926109 |
| Device Name: | FLUID DRAINAGE TRAY |
| Classification | Catheter, Irrigation |
| Applicant | SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Contact | Kevin W Smith |
| Correspondent | Kevin W Smith SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami, FL 33166 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-03 |
| Decision Date | 1993-06-07 |