Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K102582 |
Device Name |
ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE |
Applicant |
DEVON MEDICAL INC. |
1100 1ST AVENUE |
SUITE 100 |
KING OF PRUSSIA,
PA
19406
|
|
Applicant Contact |
RUTH WU |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 09/08/2010 |
Decision Date | 10/07/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|