Device Classification Name |
Nasopharyngoscope (Flexible Or Rigid)
|
510(k) Number |
K173855 |
Device Name |
Sharpsite AC Rigid Endsocope |
Applicant |
Medtronic Xomed Inc. |
6743 Southpoint Drive North |
Jacksonville,
FL
32216
|
|
Applicant Contact |
Shravan Chawla |
Correspondent |
Medtronic Xomed Inc. |
6743 Southpoint Drive North |
Jacksonville,
FL
32216
|
|
Correspondent Contact |
Shravan Chawla |
Regulation Number | 874.4760
|
Classification Product Code |
|
Date Received | 12/20/2017 |
Decision Date | 04/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|