Device Classification Name |
single use only blood lancet with an integral sharps injury prevention feature
|
510(k) Number |
K861265 |
Device Name |
DIALET LANCING DEVICE |
Applicant |
HOME DIAGNOSTICS, INC. |
51 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Applicant Contact |
JERRY B SLAVEN |
Correspondent |
HOME DIAGNOSTICS, INC. |
51 JAMES WAY |
EATONTOWN,
NJ
07724
|
|
Correspondent Contact |
JERRY B SLAVEN |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 04/04/1986 |
Decision Date | 04/30/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|