Device Classification Name |
Syringe, Piston
|
510(k) Number |
K945715 |
Device Name |
MONOJECT(R) PISTON SYRINGES; 3,6,12,20,35 AND 60CC SIZES |
Applicant |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Applicant Contact |
K M KROEHNKE |
Correspondent |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Correspondent Contact |
K M KROEHNKE |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 11/21/1994 |
Decision Date | 03/01/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|