Device Classification Name |
Syringe, Piston
|
510(k) Number |
K812934 |
Device Name |
MONOJECT PREFILLED SYRINGES |
Applicant |
SHERWOOD MEDICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SHERWOOD MEDICAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 10/20/1981 |
Decision Date | 11/06/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|