The following data is part of a premarket notification filed by Insightra Medical with the FDA for Freedom Inguinal Hernia Implant.
| Device ID | K113552 |
| 510k Number | K113552 |
| Device Name: | FREEDOM INGUINAL HERNIA IMPLANT |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Insightra Medical 9200 IRVINE CENTER DR SUITE 200 Irvine, CA 92618 |
| Contact | Wayne Noda |
| Correspondent | Wayne Noda Insightra Medical 9200 IRVINE CENTER DR SUITE 200 Irvine, CA 92618 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-01 |
| Decision Date | 2012-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00837654352885 | K113552 | 000 |
| 00837654352878 | K113552 | 000 |
| 00013964672381 | K113552 | 000 |
| 00013964672374 | K113552 | 000 |