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 |