The following data is part of a premarket notification filed by Parallax Medical, Inc. with the FDA for Parallax Cranioset.
| Device ID | K994022 |
| 510k Number | K994022 |
| Device Name: | PARALLAX CRANIOSET |
| Classification | Methyl Methacrylate For Cranioplasty |
| Applicant | PARALLAX MEDICAL, INC. 453 RAVENDALE DR., SUITE B Mountain View, CA 94043 |
| Contact | Susan Marques |
| Correspondent | Susan Marques PARALLAX MEDICAL, INC. 453 RAVENDALE DR., SUITE B Mountain View, CA 94043 |
| Product Code | GXP |
| CFR Regulation Number | 882.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-26 |
| Decision Date | 2000-08-31 |
| Summary: | summary |