Device Classification Name |
tourniquet, pneumatic
|
510(k) Number |
K112874 |
Device Name |
EZ VEIN INFLATABLE TOURNIQUET |
Applicant |
DOMINION MEDICAL DEVICES, LLC |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Applicant Contact |
ELAINE DUNCAN |
Correspondent |
DOMINION MEDICAL DEVICES, LLC |
P.O. BOX 560 |
STILLWATER,
MN
55082
|
|
Correspondent Contact |
ELAINE DUNCAN |
Regulation Number | 878.5910
|
Classification Product Code |
|
Date Received | 09/30/2011 |
Decision Date | 10/17/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|