Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K063142 |
Device Name |
MANUAL PD-IO; POWERED PD-IO |
Applicant |
VIDACARE CORPORATION |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GRACE HOLLAND |
Correspondent |
VIDACARE CORPORATION |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GRACE HOLLAND |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 10/16/2006 |
Decision Date | 12/08/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|