Device Classification Name |
Syringe, Piston
|
510(k) Number |
K021197 |
Device Name |
SUREONE INSULIN SYRINGE, 31 GAUGE X 5/16 |
Applicant |
HOSUK CO., LTD. |
5353 WAYZATA BLVD., STE 505 |
MINNEAPOLIS,
MN
55416
|
|
Applicant Contact |
CAROLE STAMP |
Correspondent |
HOSUK CO., LTD. |
5353 WAYZATA BLVD., STE 505 |
MINNEAPOLIS,
MN
55416
|
|
Correspondent Contact |
CAROLE STAMP |
Regulation Number | 880.5860
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/16/2002 |
Decision Date | 04/26/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|