The following data is part of a premarket notification filed by Nanofiber Solutions, Llc with the FDA for Rotium Bioresorbable Wick.
| Device ID | K201414 |
| 510k Number | K201414 |
| Device Name: | Rotium Bioresorbable Wick |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | Nanofiber Solutions, LLC 4389 Weaver Ct. N. Hilliard, OH 43026 |
| Contact | Jason Chakroff |
| Correspondent | Jason Chakroff Nanofiber Solutions, LLC 4389 Weaver Ct. N. Hilliard, OH 43026 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-29 |
| Decision Date | 2020-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852513007317 | K201414 | 000 |