Device Classification Name |
Bronchoscope (Flexible Or Rigid)
|
510(k) Number |
K914181 |
Device Name |
WANG/MILL-ROSE TRANSBRONCHIAL ASPIRATION NEEDLE |
Applicant |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Applicant Contact |
ALAN C POJE |
Correspondent |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Correspondent Contact |
ALAN C POJE |
Regulation Number | 874.4680
|
Classification Product Code |
|
Date Received | 09/18/1991 |
Decision Date | 12/10/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|