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 | K934072 |
| 510k Number | K934072 |
| Device Name: | CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM |
| Classification | Accessories, Catheter, G-u |
| Applicant | CONTOUR FABRICATORS OF FLORIDA, INC. 3340 SCHERER DR. St. Petersburg, FL 33716 |
| Contact | Scott Willaims |
| Correspondent | Scott Willaims CONTOUR FABRICATORS OF FLORIDA, INC. 3340 SCHERER DR. St. Petersburg, FL 33716 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1994-09-08 |