Device Classification Name |
needle, aspiration and injection, disposable
|
510(k) Number |
K945109 |
Device Name |
MONOJECT BONE MARROW BIOPSY TRAYS |
Applicant |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Applicant Contact |
FRANK J FUCILE |
Correspondent |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Correspondent Contact |
FRANK J FUCILE |
Regulation Number | 878.4800
|
Classification Product Code |
|
Date Received | 10/18/1994 |
Decision Date | 11/14/1994 |
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
|