The following data is part of a premarket notification filed by Blue Sky Bio Llc with the FDA for Blue Sky Bio Aligner.
| Device ID | K180107 |
| 510k Number | K180107 |
| Device Name: | Blue Sky Bio Aligner |
| Classification | Aligner, Sequential |
| Applicant | Blue Sky Bio LLC 888 E Belvidere Rd Suite 212 Grayslake, IL 60030 |
| Contact | Albert Zickmann |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-01-16 |
| Decision Date | 2018-02-09 |
| Summary: | summary |