The following data is part of a premarket notification filed by Steri-oss, Inc. with the FDA for Steri-oss Sinus Augmentation Kit.
| Device ID | K963897 |
| 510k Number | K963897 |
| Device Name: | STERI-OSS SINUS AUGMENTATION KIT |
| Classification | Chisel, Osteotome, Surgical |
| Applicant | STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Contact | Don Kennard |
| Correspondent | Don Kennard STERI-OSS, INC. 22895 EASTPARK DR. Yorba Linda, CA 92887 |
| Product Code | EMM |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-27 |
| Decision Date | 1996-11-06 |