The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Imz Surgical Instrument Tray.
| Device ID | K921246 |
| 510k Number | K921246 |
| Device Name: | IMZ SURGICAL INSTRUMENT TRAY |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Contact | William Franklin |
| Correspondent | William Franklin INTERPORE INTL. 18008 SKYPARK CIRCLE Irvine, CA 92714 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-16 |
| Decision Date | 1992-06-22 |