The following data is part of a premarket notification filed by Interpore Intl. with the FDA for Interpore Inducer Bone Graft Delivery Syringe.
| Device ID | K972842 |
| 510k Number | K972842 |
| Device Name: | INTERPORE INDUCER BONE GRAFT DELIVERY SYRINGE |
| Classification | Bone Grafting Material, Synthetic |
| 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 | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-01 |
| Decision Date | 1997-10-30 |
| Summary: | summary |