Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K043423 |
Device Name |
MODEL SC-3008 SEQUENTIAL CIRCULATOR |
Applicant |
BIO COMPRESSION SYSTEMS, INC. |
120 WEST COMMERCIAL AVE. |
MOONACHIE,
NJ
07074
|
|
Applicant Contact |
RON MOTHERWELL |
Correspondent |
ENTELA, INC. |
3033 MADISON AVENUE, SE |
GRAND RAPIDS,
MI
49548
|
|
Correspondent Contact |
N.E. DEVINE, JR. |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 12/13/2004 |
Decision Date | 02/01/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|