The following data is part of a premarket notification filed by Insightra Medical with the FDA for Freedom Inguinal Hernia Repair Implant-25mm/40mm/40mm With Extended Disk.
| Device ID | K140967 |
| 510k Number | K140967 |
| Device Name: | FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Insightra Medical 9200 IRVINE CENTER DR SUITE 200 Irvine, CA 92618 |
| Contact | Lisa Maloney |
| Correspondent | Lisa Maloney Insightra Medical 9200 IRVINE CENTER DR SUITE 200 Irvine, CA 92618 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00013964672367 | K140967 | 000 |
| 00013964672152 | K140967 | 000 |
| 00013964672176 | K140967 | 000 |
| 00850012832041 | K140967 | 000 |