The following data is part of a premarket notification filed by Consolidated Medical Equipment, Inc. with the FDA for I.v. Tape Down Holder.
Device ID | K800024 |
510k Number | K800024 |
Device Name: | I.V. TAPE DOWN HOLDER |
Classification | Device, Intravascular Catheter Securement |
Applicant | CONSOLIDATED MEDICAL EQUIPMENT, INC. 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 | 1980-01-07 |
Decision Date | 1980-01-29 |