The following data is part of a premarket notification filed by Sheathing Technologies, Inc. with the FDA for Sheathes Ultrasond Gel.
| Device ID | K112827 |
| 510k Number | K112827 |
| Device Name: | SHEATHES ULTRASOND GEL |
| Classification | Media, Coupling, Ultrasound |
| Applicant | SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DR. Morgan Hill, CA 95037 |
| Contact | Jennifer Downing |
| Correspondent | Jennifer Downing SHEATHING TECHNOLOGIES, INC. 18431 TECHNOLOGY DR. Morgan Hill, CA 95037 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-28 |
| Decision Date | 2012-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20842418102037 | K112827 | 000 |