Device Classification Name |
syringe, antistick
|
510(k) Number |
K092430 |
Device Name |
1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES |
Applicant |
INVIRO MEDICAL DEVICES, INC. |
1755 NORTH BROWN ROAD |
SUITE 150 |
LAWRENCEVILLE,
GA
30043
|
|
Applicant Contact |
JIM BARLEY |
Correspondent |
INVIRO MEDICAL DEVICES, INC. |
1755 NORTH BROWN ROAD |
SUITE 150 |
LAWRENCEVILLE,
GA
30043
|
|
Correspondent Contact |
JIM BARLEY |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 08/07/2009 |
Decision Date | 09/04/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|