Device Classification Name |
Multiple Use Blood Lancet For Single Patient Use Only
|
510(k) Number |
K222656 |
Device Name |
LDE4 Lancing Device |
Applicant |
i-SENS, Inc. |
43, Banpo-Daero 28-Gil, Seocho-Gu, |
Seoul,
KR
06646
|
|
Applicant Contact |
H.S. Yoo |
Correspondent |
i-SENS, Inc. |
43, Banpo-Daero 28-Gil, Seocho-Gu, |
Seoul,
KR
06646
|
|
Correspondent Contact |
H.S. Yoo |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 09/02/2022 |
Decision Date | 11/23/2022 |
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
|
|
|