The following data is part of a premarket notification filed by T.a.g. Medical Products Corporation, Ltd with the FDA for Fiberstitch Implant, Curved With Two Polyester Implants And 2-0 Fiberwire, Fiberstitch Implant, Straight With Two Polyester Implants And 2-0 Fiberwire.
| Device ID | K190125 |
| 510k Number | K190125 |
| Device Name: | FiberStitch Implant, Curved With Two Polyester Implants And 2-0 FiberWire, FiberStitch Implant, Straight With Two Polyester Implants And 2-0 FiberWire |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton, IL 2513000 |
| Contact | Shlomi Dines |
| Correspondent | Anat Rozen T.A.G. Medical Products Corporation, Ltd Gaaton Gaaton, IL 2513000 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-28 |
| Decision Date | 2019-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818674021781 | K190125 | 000 |
| 10818674027103 | K190125 | 000 |
| 10818674027110 | K190125 | 000 |
| 10818674027127 | K190125 | 000 |
| 10818674027417 | K190125 | 000 |
| 10818674027424 | K190125 | 000 |
| 10818674027264 | K190125 | 000 |
| 10818674025697 | K190125 | 000 |
| 10818674025703 | K190125 | 000 |
| 10818674021798 | K190125 | 000 |
| 10818674027097 | K190125 | 000 |