Device Classification Name |
Needle, Hypodermic, Single Lumen
|
510(k) Number |
K121632 |
Device Name |
COMFORT EZ |
Applicant |
SIMPLE DIAGNOSTICS, INC. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Applicant Contact |
DANIEL KAMM |
Correspondent |
SIMPLE DIAGNOSTICS, INC. |
8870 RAVELLO CT |
NAPLES,
FL
34114
|
|
Correspondent Contact |
DANIEL KAMM |
Regulation Number | 880.5570
|
Classification Product Code |
|
Date Received | 06/04/2012 |
Decision Date | 08/10/2012 |
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
|
|
|