The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macroporens Craniloc.
| Device ID | K002334 |
| 510k Number | K002334 |
| Device Name: | MACROPORENS CRANILOC |
| Classification | Cover, Burr Hole |
| Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Contact | Kennith K Kleinhenz |
| Correspondent | Kennith K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
| Product Code | GXR |
| CFR Regulation Number | 882.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-01 |
| Decision Date | 2001-05-02 |