Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K103587 |
Device Name |
DISPOSABLE BLLOD COLLECTION NEEDLE |
Applicant |
WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
264200
|
|
Applicant Contact |
Diana Hong |
Correspondent |
WEIHAI HONGYU MEDICAL DEVICES CO., LTD. |
P.O. BOX 237-023 |
SHANGHAI,
CN
264200
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 12/07/2010 |
Decision Date | 04/06/2011 |
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
|
|
|