Device Classification Name |
sleeve, limb, compressible
|
510(k) Number |
K190976 |
Device Name |
Radial Medical Compression System |
Applicant |
Radial Medical, Inc. |
2500 Grant Road |
Mountain View,
CA
94040
|
|
Applicant Contact |
Eric Johnson |
Correspondent |
Mark Smutka |
10984 Northseal Square |
Cupertino,
CA
95014
|
|
Correspondent Contact |
Mark Smutka |
Regulation Number | 870.5800
|
Classification Product Code |
|
Date Received | 04/15/2019 |
Decision Date | 07/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|