Device Classification Name |
single use only blood lancet with an integral sharps injury prevention feature
|
510(k) Number |
K923302 |
Device Name |
TENDERLETT FINGER |
Applicant |
INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. |
EDISON,
NJ
08820
|
|
Applicant Contact |
MATT LESNIESKI |
Correspondent |
INTERNATIONAL TECHNIDYNE CORP. |
23 NEVSKY ST. |
EDISON,
NJ
08820
|
|
Correspondent Contact |
MATT LESNIESKI |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 07/06/1992 |
Decision Date | 01/22/1993 |
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
|
Recalls |
CDRH Recalls
|