The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Suturegroove.
Device ID | K994289 |
510k Number | K994289 |
Device Name: | SUTUREGROOVE |
Classification | Weights, Eyelid, External |
Applicant | IOP, INC. 3151 AIRWAY AVE., BLDG. I-1 Costa Mesa, CA 92626 |
Contact | Jason Malecka |
Correspondent | Jason Malecka IOP, INC. 3151 AIRWAY AVE., BLDG. I-1 Costa Mesa, CA 92626 |
Product Code | MML |
CFR Regulation Number | 886.5700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-12-21 |
Decision Date | 2000-04-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SUTUREGROOVE 75897653 2589242 Live/Registered |
Advanced Meditech International, Inc. 2000-01-18 |