The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Redi Nurse System (rns) Sterile 0.9% Sodium Chloride Solution.
| Device ID | K952396 |
| 510k Number | K952396 |
| Device Name: | REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION |
| Classification | Catheters, Suction, Tracheobronchial |
| 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 | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1995-08-15 |