Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K151189 |
Device Name |
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System |
Applicant |
Devon Medical Products |
1100 First Avenue, Suite 202 |
King of Prussia,
PA
19406
|
|
Applicant Contact |
ROCCO BRAVOCO |
Correspondent |
Devon Medical Products |
1100 First Avenue, Suite 202 |
King of Prussia,
PA
19406
|
|
Correspondent Contact |
STEVE XU |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 05/04/2015 |
Decision Date | 09/18/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|