The following data is part of a premarket notification filed by Meddev Corp. with the FDA for Eyeclose External Eyelid Weights.
| Device ID | K940974 |
| 510k Number | K940974 |
| Device Name: | EYECLOSE EXTERNAL EYELID WEIGHTS |
| Classification | Weights, Eyelid, External |
| Applicant | MEDDEV CORP. P.O. BOX 1352 Los Altos, CA 94023 |
| Contact | John M Blackmore |
| Correspondent | John M Blackmore MEDDEV CORP. P.O. BOX 1352 Los Altos, CA 94023 |
| Product Code | MML |
| CFR Regulation Number | 886.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-03 |
| Decision Date | 1994-06-08 |