Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K012614 |
Device Name |
KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN |
Applicant |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
385 NORTH 3050 EAST |
ST. GEORGE,
UT
84790
|
|
Applicant Contact |
JACK SPEER |
Correspondent |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
385 NORTH 3050 EAST |
ST. GEORGE,
UT
84790
|
|
Correspondent Contact |
JACK SPEER |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 05/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|