Device Classification Name |
needle, acupuncture, single use
|
510(k) Number |
K162566 |
Device Name |
AIK Sterile Acupuncture Needles for Single Use |
Applicant |
CHANGCHUN AIK MEDICAL DEVICES CO., LTD |
NO. 25, KAREN INDUSTRIAL PARK, |
JIUTAI ECONOMIC DEVELOPMENT ZONE |
CHANGCHUN,
CN
130507
|
|
Applicant Contact |
XINGWANG LI |
Correspondent |
CHANGCHUN AIK MEDICAL DEVICES CO., LTD |
NO. 25, KAREN INDUSTRIAL PARK, |
JIUTAI ECONOMIC DEVELOPMENT ZONE |
CHANGCHUN,
CN
130507
|
|
Correspondent Contact |
XINGWANG LI |
Regulation Number | 880.5580
|
Classification Product Code |
|
Date Received | 09/14/2016 |
Decision Date | 05/11/2017 |
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
|
|
|