The following data is part of a premarket notification filed by T. G. & E. Medical with the FDA for Iv Band (intravenous Catheter Assesory).
Device ID | K860706 |
510k Number | K860706 |
Device Name: | IV BAND (INTRAVENOUS CATHETER ASSESORY) |
Classification | Device, Intravascular Catheter Securement |
Applicant | T. G. & E. MEDICAL 125 EAST IDAHO, SUITE 105 Boise, ID 83712 |
Contact | Talboy, Jr. |
Correspondent | Talboy, Jr. T. G. & E. MEDICAL 125 EAST IDAHO, SUITE 105 Boise, ID 83712 |
Product Code | KMK |
CFR Regulation Number | 880.5210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-26 |
Decision Date | 1986-03-21 |