The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Redi Nurse System (rns) Pre-filled 60cc Irrigation Syringe W/sterile Sodium Chloride Solution.
| Device ID | K952406 |
| 510k Number | K952406 |
| Device Name: | REDI NURSE SYSTEM (RNS) PRE-FILLED 60CC IRRIGATION SYRINGE W/STERILE SODIUM CHLORIDE SOLUTION |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
| Contact | Scott Wil;liams |
| Correspondent | Scott Wil;liams CONTOUR FABRICATORS OF FLORIDA, INC. 3340-D SCHERER DR. St. Petersburg, FL 33716 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-22 |
| Decision Date | 1995-08-07 |