The following data is part of a premarket notification filed by Meddev Corporation with the FDA for Contour Eyelid Weight Implants, Thinprofile Eyelid Weight Implants.
Device ID | K150986 |
510k Number | K150986 |
Device Name: | Contour Eyelid Weight Implants, ThinProfile Eyelid Weight Implants |
Classification | Weights, Eyelid, External |
Applicant | MEDDEV CORPORATION 730 NORTH PASTORIA AVE Sunnyvale, CA 94085 |
Contact | Patrick Grey |
Correspondent | Eileen Ho MEDDEV CORPORATION 730 N. Pastoria Ave Sunnyvale, CA 94085 |
Product Code | MML |
CFR Regulation Number | 886.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-04-14 |
Decision Date | 2015-08-17 |
Summary: | summary |