Device Classification Name |
Syringe, Antistick
|
510(k) Number |
K121637 |
Device Name |
AUTO-DISABLE STERILE SAFTY SYRING FOR SINGLE USE |
Applicant |
SUNWELL BIOTECH CO., LTD |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Applicant Contact |
CHARLIE MACK |
Correspondent |
SUNWELL BIOTECH CO., LTD |
77325 JOYCE WAY |
ECHO,
OR
97826
|
|
Correspondent Contact |
CHARLIE MACK |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 06/04/2012 |
Decision Date | 10/25/2012 |
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
|
|
|