The following data is part of a premarket notification filed by Pharmaceutical Innovations Inc. with the FDA for Ultra/phonic Scanning Gel.
| Device ID | K163026 |
| 510k Number | K163026 |
| Device Name: | Ultra/Phonic Scanning Gel |
| Classification | Media, Coupling, Ultrasound |
| Applicant | Pharmaceutical Innovations Inc. 897 Frelinghuysen Ave. Newark, NJ 07114 |
| Contact | Shirley J. Bergman |
| Correspondent | Shirley J. Bergman Pharmaceutical Innovations Inc. 897 Frelinghuysen Ave. Newark, NJ 07114 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-31 |
| Decision Date | 2018-01-09 |
| Summary: | summary |