Device Classification Name |
syringe, piston
|
510(k) Number |
K944920 |
Device Name |
CG DISPOSABLE SYRINGE |
Applicant |
FORTUNIQUE MEDICAL PRODUCTS |
28TH FLOOR, UBN TOWER, NO. 10 |
JALAN P. RAMLEE |
KUALA LUMPUR,
MY
50250
|
|
Applicant Contact |
CHARLES M HUBBS |
Correspondent |
FORTUNIQUE MEDICAL PRODUCTS |
28TH FLOOR, UBN TOWER, NO. 10 |
JALAN P. RAMLEE |
KUALA LUMPUR,
MY
50250
|
|
Correspondent Contact |
CHARLES M HUBBS |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/06/1994 |
Decision Date | 12/20/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|