Device Classification Name |
system, imaging, pulsed echo, ultrasonic
|
510(k) Number |
K113680 |
Device Name |
SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KIT |
Applicant |
SOMA ACCESS SYSTEMS LLC |
109 LAUREN ROAD, SUITE 4C |
GREENVILLE,
SC
29607
|
|
Applicant Contact |
GENOA ATWOOD |
Correspondent |
REGULATORY TECHNOLOGY SERVICES, LLC |
1000 Westgate Drive, |
Suite 510k |
Saint Paul,
MN
55114
|
|
Correspondent Contact |
MARK JOB |
Regulation Number | 892.1560
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/15/2011 |
Decision Date | 12/29/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|