The following data is part of a premarket notification filed by T. G. & E. Medical with the FDA for Cannula Band.
Device ID | K860261 |
510k Number | K860261 |
Device Name: | CANNULA BAND |
Classification | Cannula, Nasal, Oxygen |
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 | CAT |
CFR Regulation Number | 868.5340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-24 |
Decision Date | 1986-02-18 |