The following data is part of a premarket notification filed by Rand Scientific Corp. with the FDA for Medial Malar Implant.
| Device ID | K961080 |
| 510k Number | K961080 |
| Device Name: | MEDIAL MALAR IMPLANT |
| Classification | Implant, Malar |
| Applicant | RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
| Contact | Duane Tracy |
| Correspondent | Duane Tracy RAND SCIENTIFIC CORP. 4135 NORTHGATE BLVD., SUITE 9 Sacramento, CA 95834 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-18 |
| Decision Date | 1996-04-19 |