The following data is part of a premarket notification filed by Citation Medical Corp. with the FDA for Citation Sinuscope.
Device ID | K951249 |
510k Number | K951249 |
Device Name: | CITATION SINUSCOPE |
Classification | Nasopharyngoscope (flexible Or Rigid) |
Applicant | CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
Contact | Roger Kreibdberg |
Correspondent | Roger Kreibdberg CITATION MEDICAL CORP. 230 EDISON WAY Reno, NV 89502 |
Product Code | EOB |
CFR Regulation Number | 874.4760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-20 |
Decision Date | 1995-04-10 |