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 |