The following data is part of a premarket notification filed by International Life Sciences with the FDA for Flexband Plus.
| Device ID | K192112 |
| 510k Number | K192112 |
| Device Name: | FlexBand Plus |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | International Life Sciences 2252 Northwest Parkway SE Marietta, GA 30067 |
| Contact | Tiffini Wittwer |
| Correspondent | Tiffini Wittwer International Life Sciences 2252 Northwest Parkway SE Marietta, GA 30067 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-05 |
| Decision Date | 2019-09-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850003396101 | K192112 | 000 |
| 00850003396286 | K192112 | 000 |
| 00850003396163 | K192112 | 000 |
| 00850003396170 | K192112 | 000 |
| 00850003396026 | K192112 | 000 |
| 00850003396033 | K192112 | 000 |
| 00850003396040 | K192112 | 000 |
| 00850003396057 | K192112 | 000 |
| 00850003396064 | K192112 | 000 |
| 00850003396071 | K192112 | 000 |
| 00850003396088 | K192112 | 000 |
| 00850003396095 | K192112 | 000 |
| 00850003396187 | K192112 | 000 |