The following data is part of a premarket notification filed by Relign Corporation with the FDA for Relign System.
| Device ID | K162770 |
| 510k Number | K162770 |
| Device Name: | Relign System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Relign Corporation 1601 South De Anza Boulevard, Suite 200 Cupertino, CA 95014 |
| Contact | Nathan Nguyen |
| Correspondent | Nathan Nguyen Relign Corporation 1601 South De Anza Boulevard, Suite 200 Cupertino, CA 95014 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-03 |
| Decision Date | 2017-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08592730070030 | K162770 | 000 |
| 10859273007264 | K162770 | 000 |
| 10859273007127 | K162770 | 000 |
| 10859273007240 | K162770 | 000 |
| 00859273007212 | K162770 | 000 |
| 00859273007236 | K162770 | 000 |
| 10859273007080 | K162770 | 000 |
| 00859273007014 | K162770 | 000 |
| 00859273007021 | K162770 | 000 |
| 00859273007038 | K162770 | 000 |
| 10859273007059 | K162770 | 000 |
| 00859273007113 | K162770 | 000 |
| 10859273007141 | K162770 | 000 |
| 10859273007172 | K162770 | 000 |
| 08592730070146 | K162770 | 000 |
| 18592730070174 | K162770 | 000 |
| 10859273007257 | K162770 | 000 |