Device Classification Name |
Instrument, Biopsy, Suction
|
510(k) Number |
K895420 |
Device Name |
SUCTION BIOPSY INSTRUMENT |
Applicant |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Applicant Contact |
MARK KOZAK |
Correspondent |
MILL-ROSE LABORATORY |
7310 CORPORATE BLVD. |
MENTOR,
OH
44060 -4885
|
|
Correspondent Contact |
MARK KOZAK |
Regulation Number | 876.1075
|
Classification Product Code |
|
Date Received | 09/01/1989 |
Decision Date | 02/09/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|