The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Ear And Nose Specula.
Device ID | K791123 |
510k Number | K791123 |
Device Name: | EAR AND NOSE SPECULA |
Classification | Speculum, Ent |
Applicant | XOMED, INC. 1318 LONEDELL RD. Arnold, MO 63010 |
Product Code | EPY |
CFR Regulation Number | 878.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-06-15 |
Decision Date | 1979-07-10 |