The following data is part of a premarket notification filed by Marketing Solutions Inc. with the FDA for Pelvimesh / Hermesh 7.
| Device ID | K070625 |
| 510k Number | K070625 |
| Device Name: | PELVIMESH / HERMESH 7 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | MARKETING SOLUTIONS INC. 8 ORANGE DR. Jericho, NY 11753 |
| Contact | Lorena Trabucco |
| Correspondent | Lorena Trabucco MARKETING SOLUTIONS INC. 8 ORANGE DR. Jericho, NY 11753 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-06 |
| Decision Date | 2007-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 58032919891322 | K070625 | 000 |