The following data is part of a premarket notification filed by Ebi, L.p. with the FDA for Ebi Lactosorb Graft Containment System.
| Device ID | K033918 |
| 510k Number | K033918 |
| Device Name: | EBI LACTOSORB GRAFT CONTAINMENT SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Contact | Jon Caparotta |
| Correspondent | Jon Caparotta EBI, L.P. 399 JEFFERSON ROAD Parsippany, NJ 07054 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-18 |
| Decision Date | 2004-08-16 |
| Summary: | summary |