Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K943485 |
Device Name |
MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER |
Applicant |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Applicant Contact |
MICHAEL KROEHNKE |
Correspondent |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Correspondent Contact |
MICHAEL KROEHNKE |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 07/19/1994 |
Decision Date | 09/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|