The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Ip 200 Granular Coralline Hydroxyapatite Bone Void Fillers, 425 To 1000 Microns And 425 To 600 Microns.
| Device ID | K950165 |
| 510k Number | K950165 |
| Device Name: | INTERPORE IP 200 GRANULAR CORALLINE HYDROXYAPATITE BONE VOID FILLERS, 425 TO 1000 MICRONS AND 425 TO 600 MICRONS |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Contact | William A Franklin |
| Correspondent | William A Franklin INTERPORE INTL. 181 TECHNOLOGY DR. Irvine, CA 92618 -2402 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-17 |
| Decision Date | 1995-03-28 |