The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Imz Cyl Implant & Cyl Hex Implt.
| Device ID | K955492 |
| 510k Number | K955492 |
| Device Name: | INTERPORE IMZ CYL IMPLANT & CYL HEX IMPLT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | David P Balding |
| Correspondent | David P Balding INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-01 |
| Decision Date | 1996-01-30 |