The following data is part of a premarket notification filed by Hpd Medical, Inc. with the FDA for Cath-lok.
| Device ID | K821957 |
| 510k Number | K821957 |
| Device Name: | CATH-LOK |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | HPD MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-30 |
| Decision Date | 1982-07-28 |