Device Classification Name |
syringe, antistick
|
510(k) Number |
K031909 |
Device Name |
BETEC RETRACTABLE SAFETY SYRINGE (5ML) |
Applicant |
BETEC MEDICAL SCIENCE CO., LTD. |
3892 SOUTH AMERICA WEST TRAIL |
FLAGGSTAFF,
AZ
86001
|
|
Applicant Contact |
JENNIFER REICH |
Correspondent |
BETEC MEDICAL SCIENCE CO., LTD. |
3892 SOUTH AMERICA WEST TRAIL |
FLAGGSTAFF,
AZ
86001
|
|
Correspondent Contact |
JENNIFER REICH |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 06/20/2003 |
Decision Date | 10/07/2003 |
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
|
|
|