The following data is part of a premarket notification filed by K-lok, Inc. with the FDA for K-lok Catheter Securement Device Modification.
| Device ID | K935252 |
| 510k Number | K935252 |
| Device Name: | K-LOK CATHETER SECUREMENT DEVICE MODIFICATION |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | K-LOK, INC. 1120 HOLLAND DR. SUITE 14 Boca Raton, FL 33487 |
| Contact | Glenda Kalt |
| Correspondent | Glenda Kalt K-LOK, INC. 1120 HOLLAND DR. SUITE 14 Boca Raton, FL 33487 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-07 |
| Decision Date | 1994-02-18 |