Device Classification Name |
source, brachytherapy, radionuclide
|
510(k) Number |
K902622 |
Device Name |
MANAN PROSTATE SEEDING 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 | 892.5730
|
Classification Product Code |
|
Date Received | 06/14/1990 |
Decision Date | 08/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|