Device Classification Name |
single use only blood lancet with an integral sharps injury prevention feature
|
510(k) Number |
K153670 |
Device Name |
Genteel Lancing Device |
Applicant |
Genteel, LLC |
4011 Livingstone St. |
Midland,
TX
79707
|
|
Applicant Contact |
Christopher Jacobs |
Correspondent |
Duval & Associates, P.A. |
825 Nicollet Mall, Suite 1820 |
Minneapolis,
MN
55402
|
|
Correspondent Contact |
Mark DuVal |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 12/21/2015 |
Decision Date | 05/12/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|