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 |