| Device Classification Name |
Syringe, Piston
|
| 510(k) Number |
K944542 |
| Device Name |
REUSABLE ALL - GLASS SYRINGES |
| Applicant |
| Top Syringe Mfg. Co. |
| 317-21, Dr.D.Rd.,Fort |
|
Bombay,
IN
400 001
|
|
| Applicant Contact |
N TALUKDAR |
| Correspondent |
| Top Syringe Mfg. Co. |
| 317-21, Dr.D.Rd.,Fort |
|
Bombay,
IN
400 001
|
|
| Correspondent Contact |
N TALUKDAR |
| Regulation Number | 880.5860 |
| Classification Product Code |
|
| Date Received | 09/16/1994 |
| Decision Date | 09/29/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|