Device Classification Name |
Clamp, Vascular
|
510(k) Number |
K152525 |
FOIA Releasable 510(k) |
K152525
|
Device Name |
TR BAND Radial Compression Device |
Applicant |
TERUMO MEDICAL CORPORATION |
950 ELKTON BLVD |
ELKTON,
MD
21921
|
|
Applicant Contact |
LIANG LU |
Correspondent |
TERUMO MEDICAL CORPORATION |
950 ELKTON BLVD |
ELKTON,
MD
21921
|
|
Correspondent Contact |
LIANG LU |
Regulation Number | 870.4450
|
Classification Product Code |
|
Date Received | 09/03/2015 |
Decision Date | 11/10/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|