The following data is part of a premarket notification filed by Blue Sky Bio, Llc with the FDA for Blue Sky Bio Tcp.
| Device ID | K110198 |
| 510k Number | K110198 |
| Device Name: | BLUE SKY BIO TCP |
| Classification | Bone Grafting Material, For Dental Bone Repair |
| Applicant | BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030 |
| Contact | Michele Vovolka |
| Correspondent | Michele Vovolka BLUE SKY BIO, LLC 888 E BELVIDERE RD. SUITE 212 Grayslake, IL 60030 |
| Product Code | LPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-24 |
| Decision Date | 2011-12-22 |
| Summary: | summary |