Device Classification Name |
single use only blood lancet with an integral sharps injury prevention feature
|
510(k) Number |
K942548 |
Device Name |
JENNINGS JAVELIN |
Applicant |
JFI ENDINEERING, INC. |
380 CLINTON ST. |
COSTA MESA,
CA
92626
|
|
Applicant Contact |
STEPHEN J COONAN |
Correspondent |
JFI ENDINEERING, INC. |
380 CLINTON ST. |
COSTA MESA,
CA
92626
|
|
Correspondent Contact |
STEPHEN J COONAN |
Regulation Number | 878.4850
|
Classification Product Code |
|
Date Received | 05/31/1994 |
Decision Date | 11/03/1994 |
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
|