Device Classification Name |
Needle, Aspiration And Injection, Reusable
|
510(k) Number |
K772293 |
Device Name |
BONE MARROW BIOPSY DEVICE |
Applicant |
RADIATION DEVELOPMENT CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
RADIATION DEVELOPMENT CO., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 12/12/1977 |
Decision Date | 01/03/1978 |
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
|