Device Classification Name |
Set, Administration, Intravascular
|
510(k) Number |
K942271 |
Device Name |
LEVEL 1* INJECT NEEDLE-FREE INJECTION SITE |
Applicant |
LEVEL 1 TECHNOLOGIES, INC. |
160 WEYMOUTH ST. |
ROCKLAND,
MA
02370
|
|
Applicant Contact |
NANCY HASKINS-LEBLANC |
Correspondent |
LEVEL 1 TECHNOLOGIES, INC. |
160 WEYMOUTH ST. |
ROCKLAND,
MA
02370
|
|
Correspondent Contact |
NANCY HASKINS-LEBLANC |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 05/10/1994 |
Decision Date | 07/12/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|