The following data is part of a premarket notification filed by Advance Medical Designs, Inc. with the FDA for Advance Medical Designs, Inc. Sterile Ultrasound Gel.
| Device ID | K163050 |
| 510k Number | K163050 |
| Device Name: | Advance Medical Designs, Inc. Sterile Ultrasound Gel |
| Classification | Media, Coupling, Ultrasound |
| Applicant | ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta, GA 30066 |
| Contact | David Mackie |
| Correspondent | David Mackie ADVANCE MEDICAL DESIGNS, INC. 1241 ATLANTA INDUSTRIAL DR. Marietta, GA 30066 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10848340014854 | K163050 | 000 |