Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K090308 |
Device Name |
RESTEP DVY SYSTEM, MODEL RSP-101 |
Applicant |
STORTFORD MEDICAL LLC |
295 PRINCETON HIGHTSTOWN ROAD |
UNIT 321 |
WEST WINDSOR,
NJ
08550
|
|
Applicant Contact |
CHRIS DAUGHTERY |
Correspondent |
STORTFORD MEDICAL LLC |
295 PRINCETON HIGHTSTOWN ROAD |
UNIT 321 |
WEST WINDSOR,
NJ
08550
|
|
Correspondent Contact |
CHRIS DAUGHTERY |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 02/06/2009 |
Decision Date | 05/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|