Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K061967 |
Device Name |
SCD GARMENT, MODEL VP530 |
Applicant |
COMPRESSION THERAPY CONCEPTS, INC. |
1750 BRIELLE AVE. |
SUITE B6 |
WANAMASSA,
NJ
07712
|
|
Applicant Contact |
LEN NASS |
Correspondent |
COMPRESSION THERAPY CONCEPTS, INC. |
1750 BRIELLE AVE. |
SUITE B6 |
WANAMASSA,
NJ
07712
|
|
Correspondent Contact |
LEN NASS |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 07/12/2006 |
Decision Date | 09/25/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|