The following data is part of a premarket notification filed by Integra Lifesciences Corporation (owner Of Tei Biosciences) with the FDA for Surgimend Prs Meshed, Revize-x.
| Device ID | K171357 |
| 510k Number | K171357 |
| Device Name: | SurgiMend PRS Meshed, Revize-X |
| Classification | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
| Applicant | Integra LifeSciences Corporation (Owner Of TEI Biosciences) 7 Elkins Street Boston, MA 02127 |
| Contact | Kavita Amin |
| Correspondent | Kavita Amin Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | OXH |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-09 |
| Decision Date | 2017-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780357322 | K171357 | 000 |
| 10381780357315 | K171357 | 000 |
| 10381780357308 | K171357 | 000 |