Device Classification Name |
transducer, ultrasonic, diagnostic
|
510(k) Number |
K123424 |
Device Name |
MDU5 PLUS STERILE BAG |
Applicant |
BOSTON SCIENTIFIC CORP. |
47215 LAKEVIEW BOULEVARD |
FREMONT,
CA
94538
|
|
Applicant Contact |
LORI R SMITH |
Correspondent |
BOSTON SCIENTIFIC CORP. |
47215 LAKEVIEW BOULEVARD |
FREMONT,
CA
94538
|
|
Correspondent Contact |
LORI R SMITH |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 11/07/2012 |
Decision Date | 02/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|