Device Classification Name |
mediastinoscope, surgical
|
510(k) Number |
K170757 |
Device Name |
Aegis Transit System |
Applicant |
Boston-Biomedical Associates |
100 Crowley Drive, Suite 216 |
Marlborough,
MA
01752
|
|
Applicant Contact |
Lauren Baker |
Correspondent |
Boston-Biomedical Associates |
100 Crowley Drive, Suite 216 |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Lauren Baker |
Regulation Number | 874.4720
|
Classification Product Code |
|
Date Received | 03/13/2017 |
Decision Date | 07/14/2017 |
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
|
|
|