The following data is part of a premarket notification filed by Medway with the FDA for Comfor-board.
| Device ID | K910880 |
| 510k Number | K910880 |
| Device Name: | COMFOR-BOARD |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
| Contact | James J Callaway |
| Correspondent | James J Callaway MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-06-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() COMFOR-BOARD 74149872 not registered Dead/Abandoned |
MEDWAY, INC. 1991-03-21 |