Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K181069 |
Device Name |
Disposable Insulin Pen Needle |
Applicant |
Zhejiang Kindly Medical Devices Co. Ltd |
No.758, 5th Binhai Road, Binhai Industrial Park |
Longwan District |
Wenzhou,
CN
325000
|
|
Applicant Contact |
Yong Zhang |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 04/23/2018 |
Decision Date | 08/28/2018 |
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
|
|
|