The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Odontit Autogenous Bone Collection Device.
| Device ID | K971036 |
| 510k Number | K971036 |
| Device Name: | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | Mario Gersberg |
| Correspondent | Mario Gersberg INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-06-03 |
| Summary: | summary |