Device Classification Name |
sharps needle destruction device
|
510(k) Number |
K202073 |
Device Name |
NeedleSmart Professional (NS Pro) |
Applicant |
NeedleSmart Limited |
Suite 2B, Stanley Grange Business Park, Ormskirk Road, |
Knowsley, Prescot,
GB
L34 5NB
|
|
Applicant Contact |
Tom Baker |
Correspondent |
NeedleSmart Limited |
Suite 2B, Stanley Grange Business Park, Ormskirk Road, |
Knowsley, Prescot,
GB
L34 5NB
|
|
Correspondent Contact |
Tom Baker |
Regulation Number | 880.6210
|
Classification Product Code |
|
Date Received | 07/27/2020 |
Decision Date | 03/25/2021 |
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
|
|
|