The following data is part of a premarket notification filed by Pacific Materials And Interfaces with the FDA for Macropore Protective Sheet.
| Device ID | K983360 |
| 510k Number | K983360 |
| Device Name: | MACROPORE PROTECTIVE SHEET |
| Classification | Plate, Bone |
| Applicant | PACIFIC MATERIALS AND INTERFACES 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson PACIFIC MATERIALS AND INTERFACES 4329 GRAYDON RD. San Diego, CA 92130 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-24 |
| Decision Date | 1999-03-19 |
| Summary: | summary |