The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macroporepx Pediatric System.
| Device ID | K002207 |
| 510k Number | K002207 |
| Device Name: | MACROPOREPX PEDIATRIC SYSTEM |
| Classification | Plate, Bone |
| Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Contact | Kenneth K Kleinhenz |
| Correspondent | Kenneth K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-21 |
| Decision Date | 2001-07-11 |