The following data is part of a premarket notification filed by Pacific Materials And Interfaces with the FDA for Macropore Protective Sheet (protego System).
| Device ID | K972913 |
| 510k Number | K972913 |
| Device Name: | MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM) |
| Classification | Plate, Fixation, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-07 |
| Decision Date | 1998-07-30 |
| Summary: | summary |