Device Classification Name |
device, counter-pulsating, external
|
510(k) Number |
K082134 |
Device Name |
CIRCULATOR BOOT |
Applicant |
CIRCULATOR BOOT CORP. |
72 PENNSYLVANIA AVE. |
MALVERN,
PA
19355
|
|
Applicant Contact |
RICHARD S DILLON |
Correspondent |
CIRCULATOR BOOT CORP. |
72 PENNSYLVANIA AVE. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
RICHARD S DILLON |
Regulation Number | 870.5225
|
Classification Product Code |
|
Date Received | 07/29/2008 |
Decision Date | 05/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|