The following data is part of a premarket notification filed by H & P Industries, Inc. with the FDA for Tria-sonic Ultra Sound Transmission Gel.
Device ID | K901217 |
510k Number | K901217 |
Device Name: | TRIA-SONIC ULTRA SOUND TRANSMISSION GEL |
Classification | Electrode, Gel, Electrosurgical |
Applicant | H & P INDUSTRIES, INC. 9640 S 60TH ST. Franklin, WI 53132 |
Contact | George Horvat |
Correspondent | George Horvat H & P INDUSTRIES, INC. 9640 S 60TH ST. Franklin, WI 53132 |
Product Code | JOT |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-13 |
Decision Date | 1990-06-22 |