Device Classification Name |
pump, infusion
|
510(k) Number |
K962709 |
Device Name |
SIGMA SYRINGE DELIVERY SYSTEM(MULTI-DOSER REV. 1/MULTI-DOSER REV. II/SINGLE-DOSER REV. 1-10/SINGLE-DOSER REV. 1-20/ |
Applicant |
SIGMA INTL. |
711 PARK AVE. |
MEDINA,
NY
14103 -0756
|
|
Applicant Contact |
PATRICK W PENQUE |
Correspondent |
SIGMA INTL. |
711 PARK AVE. |
MEDINA,
NY
14103 -0756
|
|
Correspondent Contact |
PATRICK W PENQUE |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/12/1996 |
Decision Date | 10/07/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|