The following data is part of a premarket notification filed by Tapemark Co. with the FDA for Intravascular Catheter Securement Dev.
Device ID | K841487 |
510k Number | K841487 |
Device Name: | INTRAVASCULAR CATHETER SECUREMENT DEV |
Classification | Device, Intravascular Catheter Securement |
Applicant | TAPEMARK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-10 |
Decision Date | 1984-06-28 |