Device Classification Name |
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
|
510(k) Number |
K870017 |
Device Name |
AMG + MED LANCET |
Applicant |
CAN-AM SURGICAL CORP. |
3068 STONEWOOD ST. |
SIMI VALLEY,
CA
93063
|
|
Applicant Contact |
ALLAN GOLDENBERG |
Correspondent |
CAN-AM SURGICAL CORP. |
3068 STONEWOOD ST. |
SIMI VALLEY,
CA
93063
|
|
Correspondent Contact |
ALLAN GOLDENBERG |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 01/02/1987 |
Decision Date | 01/21/1987 |
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
|