The following data is part of a premarket notification filed by Contour Fabricators Of Florida, Inc. with the FDA for Rns Arthrogram Tray.
| Device ID | K962040 |
| 510k Number | K962040 |
| Device Name: | RNS ARTHROGRAM TRAY |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CONTOUR FABRICATORS OF FLORIDA, INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Contact | Pat Lamb |
| Correspondent | Pat Lamb CONTOUR FABRICATORS OF FLORIDA, INC. 40178 U.S. 19 NORTH Tarpon Springs, FL 34689 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-24 |
| Decision Date | 1996-06-25 |