Device Classification Name |
Brush, Biopsy, Bronchoscope (Non-Rigid)
|
510(k) Number |
K820771 |
Device Name |
MICROBIOLOGY SPECIMEN BRUSH |
Applicant |
MILL-ROSE LABORATORY |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MILL-ROSE LABORATORY |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 03/23/1982 |
Decision Date | 05/03/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Microbiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|