The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Vivosonic Dianostic Ultrasound Imaging Coupling Media.
| Device ID | K020956 |
| 510k Number | K020956 |
| Device Name: | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA |
| Classification | Media, Coupling, Ultrasound |
| Applicant | MICROTEK MEDICAL, INC. 602 LEHMBERG RD. Columbus, MS 39702 |
| Contact | Thomas Bonner |
| Correspondent | Thomas Bonner MICROTEK MEDICAL, INC. 602 LEHMBERG RD. Columbus, MS 39702 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-05-16 |
| Summary: | summary |