The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Convenience Contour Kits Redi Nurse System.
| Device ID | K935092 |
| 510k Number | K935092 |
| Device Name: | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM |
| Classification | Syringe, Piston |
| Applicant | CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
| Contact | Scott Williams |
| Correspondent | Scott Williams CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-25 |
| Decision Date | 1994-06-10 |