The following data is part of a premarket notification filed by Apatech Ltd. with the FDA for Pore-si Bone Graft Substitute.
| Device ID | K040082 |
| 510k Number | K040082 |
| Device Name: | PORE-SI BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | APATECH LTD. 195 WEST ST. Waltham, MA 02451 |
| Contact | Barry Sall |
| Correspondent | Barry Sall APATECH LTD. 195 WEST ST. Waltham, MA 02451 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-15 |
| Decision Date | 2004-08-04 |
| Summary: | summary |