Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K932785 |
Device Name |
MONOJECT(R) MONOLETTOR SAFETY LANCET |
Applicant |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Applicant Contact |
DENNIS POZZO |
Correspondent |
SHERWOOD MEDICAL CO. |
1915 OLIVE ST. |
ST. LOUIS,
MO
63103 -1625
|
|
Correspondent Contact |
DENNIS POZZO |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 06/09/1993 |
Decision Date | 09/29/1993 |
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
|