The following data is part of a premarket notification filed by Calcitek, Inc. with the FDA for Calcitite Bone Graft Mat/oral & Maxillofacial Surg.
| Device ID | K852682 |
| 510k Number | K852682 |
| Device Name: | CALCITITE BONE GRAFT MAT/ORAL & MAXILLOFACIAL SURG |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CALCITEK, INC. 4125-B SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Richard Hunter |
| Correspondent | Richard Hunter CALCITEK, INC. 4125-B SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-25 |
| Decision Date | 1985-09-23 |