Device Classification Name |
Media, Coupling, Ultrasound
|
510(k) Number |
K151070 |
Device Name |
Sonishield 100 Antimicrobial Ultrasound Gel |
Applicant |
Quotient Medical |
3365 Harvester Road, Suite 110 |
Burlington,
CA
L7N 3N2
|
|
Applicant Contact |
David Okamoto |
Correspondent |
Lockhart Regulatory Services Inc. |
1860 Appleby Line, Suite 348 |
Burlington,
CA
L7L 7H7
|
|
Correspondent Contact |
Marilyn Lockhart |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 04/21/2015 |
Decision Date | 01/13/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|