Device Classification Name |
needle, hypodermic, single lumen
|
510(k) Number |
K160805 |
Device Name |
NIO-P |
Applicant |
WAISMED LTD. |
10 AMAL ST. AFEK INDUSTRIAL PARK, |
Rosh Ha'Ayin,
IL
4809234
|
|
Applicant Contact |
Einat Swisa |
Correspondent |
HOGAN LOVELLS US LLP |
COLUMBIA SQUARE, 555 THIRTEENTH ST |
Washington,
DC
20004
|
|
Correspondent Contact |
Jonathan S. Kahan |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 03/23/2016 |
Decision Date | 06/23/2016 |
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
|
Recalls |
CDRH Recalls
|
|
|