The following data is part of a premarket notification filed by Meddev Corp. with the FDA for Contour Design Gold Eyelid Implant, Model Contour Design (series 3000).
| Device ID | K011740 |
| 510k Number | K011740 |
| Device Name: | CONTOUR DESIGN GOLD EYELID IMPLANT, MODEL CONTOUR DESIGN (SERIES 3000) |
| Classification | Weights, Eyelid, External |
| Applicant | MEDDEV CORP. 730 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Contact | Suzanna Brick |
| Correspondent | Suzanna Brick MEDDEV CORP. 730 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Product Code | MML |
| CFR Regulation Number | 886.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-05 |
| Decision Date | 2001-07-02 |
| Summary: | summary |