The following data is part of a premarket notification filed by Swedish Trade Council Usa with the FDA for Sterile Ultrasound Transmission Gel.
| Device ID | K894490 |
| 510k Number | K894490 |
| Device Name: | STERILE ULTRASOUND TRANSMISSION GEL |
| Classification | Electrode, Gel, Electrosurgical |
| Applicant | SWEDISH TRADE COUNCIL USA 150 NORTH MICHIGAN AVE. SUITE 1200 Chicago, IL 60601 |
| Contact | Carl-anders Sjoberg |
| Correspondent | Carl-anders Sjoberg SWEDISH TRADE COUNCIL USA 150 NORTH MICHIGAN AVE. SUITE 1200 Chicago, IL 60601 |
| Product Code | JOT |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-18 |
| Decision Date | 1989-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350025911660 | K894490 | 000 |