Device Classification Name |
Sleeve, Limb, Compressible
|
510(k) Number |
K003857 |
Device Name |
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES |
Applicant |
STERILMED, INC. |
3650 ANNAPOLIS LN. NORTH |
SUITE 170 |
PLYMOUTH,
MN
55447
|
|
Applicant Contact |
PATRICK FLEISCHHACKER |
Correspondent |
STERILMED, INC. |
3650 ANNAPOLIS LN. NORTH |
SUITE 170 |
PLYMOUTH,
MN
55447
|
|
Correspondent Contact |
PATRICK FLEISCHHACKER |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 12/13/2000 |
Decision Date | 10/18/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|