Device Classification Name |
syringe, piston
|
510(k) Number |
K852544 |
Device Name |
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES |
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 | 880.5860
|
Classification Product Code |
|
Date Received | 06/14/1985 |
Decision Date | 07/23/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|