The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for The Denver Splint.
Device ID | K791681 |
510k Number | K791681 |
Device Name: | THE DENVER SPLINT |
Classification | Splint, Nasal |
Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
Product Code | EPP |
CFR Regulation Number | 874.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-28 |
Decision Date | 1979-10-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() THE DENVER SPLINT 73492232 1392241 Live/Registered |
DENVER SPLINT CO., INC., THE 1984-07-30 |
![]() THE DENVER SPLINT 73293293 1214487 Dead/Cancelled |
Denver Splint Company, Incorporated, The 1981-01-16 |