The following data is part of a premarket notification filed by International Trade Group, Inc. with the FDA for Yarlap Ii.
| Device ID | K160773 |
| 510k Number | K160773 |
| Device Name: | Yarlap II |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LANE Oxford, OH 45056 |
| Contact | Brent C. Reider |
| Correspondent | Brent C. Reider INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LANE Oxford, OH 45056 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-21 |
| Decision Date | 2016-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000860031 | K160773 | 000 |