Device Classification Name |
Needle, Biopsy, Cardiovascular
|
510(k) Number |
K890925 |
Device Name |
MANAN BONE MARROW BIOPSY NEEDLE |
Applicant |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. |
NORTHBROOK,
IL
60062
|
|
Applicant Contact |
MANFRED MITTERMEIER |
Correspondent |
MANAN MEDICAL PRODUCTS, INC. |
2200 CARLSON DR. |
NORTHBROOK,
IL
60062
|
|
Correspondent Contact |
MANFRED MITTERMEIER |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 02/24/1989 |
Decision Date | 04/11/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|