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 |