Device Classification Name |
chamber, oxygen, topical, extremity
|
510(k) Number |
K090681 |
Device Name |
TANSCU O2 |
Applicant |
ELECTROCHEMICAL OXYGEN CONCEPTS, INC. |
10 E SCRANTON AVE |
SUITE 201 |
LAKE BLUFF,
IL
60044
|
|
Applicant Contact |
CARL JENKINS |
Correspondent |
ELECTROCHEMICAL OXYGEN CONCEPTS, INC. |
10 E SCRANTON AVE |
SUITE 201 |
LAKE BLUFF,
IL
60044
|
|
Correspondent Contact |
CARL JENKINS |
Regulation Number | 878.5650
|
Classification Product Code |
|
Date Received | 03/16/2009 |
Decision Date | 08/12/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|