Device Classification Name |
Media, Coupling, Ultrasound
|
510(k) Number |
K163024 |
Device Name |
Ultra/Phonic Conductivity Gel |
Applicant |
PHARMACEUTICAL INNOVATIONS, INC. |
897 FRELINGHUYSEN AVE. |
NEWARK,
NJ
07114
|
|
Applicant Contact |
SHIRLEY J. BERGMAN |
Correspondent |
PHARMACEUTICAL INNOVATIONS, INC. |
897 FRELINGHUYSEN AVE. |
NEWARK,
NJ
07114
|
|
Correspondent Contact |
SHIRLEY J. BERGMAN |
Regulation Number | 892.1570
|
Classification Product Code |
|
Date Received | 10/31/2016 |
Decision Date | 01/08/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|