The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macrosorbos Protective Sheet.
| Device ID | K994158 |
| 510k Number | K994158 |
| Device Name: | MACROSORBOS PROTECTIVE SHEET |
| Classification | Plate, Fixation, Bone |
| Applicant | MACROPORE BIOSURGERY, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson MACROPORE BIOSURGERY, INC. 4329 GRAYDON RD. San Diego, CA 92130 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 2000-07-24 |
| Summary: | summary |