The following data is part of a premarket notification filed by International Trade Group, Inc. with the FDA for Yarlap.
| Device ID | K141643 |
| 510k Number | K141643 |
| Device Name: | YARLAP |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. SUITE O Oxford, OH 45056 |
| Contact | Brent C Reider |
| Correspondent | Brent C Reider INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. SUITE O 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 | 2014-06-19 |
| Decision Date | 2015-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860000860000 | K141643 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() YARLAP 86676589 4895297 Live/Registered |
International Trade Group, Inc. 2015-06-28 |