Device Classification Name |
single use only blood lancet with an integral sharps injury prevention feature
|
510(k) Number |
K931481 |
Device Name |
MINI-LANCET |
Applicant |
PACIFIC RIM PRODUCTS, INC. |
80 BELFORD RD. EAST KEW |
3103 MELBOURNE |
AUSTRALIA,
AU
|
|
Applicant Contact |
JOHN HEWITT |
Correspondent |
PACIFIC RIM PRODUCTS, INC. |
80 BELFORD RD. EAST KEW |
3103 MELBOURNE |
AUSTRALIA,
AU
|
|
Correspondent Contact |
JOHN HEWITT |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 03/24/1993 |
Decision Date | 10/01/1993 |
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
|