Device Classification Name |
Electrode, Gel, Electrosurgical
|
510(k) Number |
K901217 |
Device Name |
TRIA-SONIC ULTRA SOUND TRANSMISSION GEL |
Applicant |
H & P INDUSTRIES, INC. |
9640 S 60TH ST. |
FRANKLIN,
WI
53132
|
|
Applicant Contact |
GEORGE HORVAT |
Correspondent |
H & P INDUSTRIES, INC. |
9640 S 60TH ST. |
FRANKLIN,
WI
53132
|
|
Correspondent Contact |
GEORGE HORVAT |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/13/1990 |
Decision Date | 06/22/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|