The following data is part of a premarket notification filed by Rim-wide Companies, Inc. with the FDA for Lenserver Automatic Contact Lens Cleaning Accessory.
Device ID | K982115 |
510k Number | K982115 |
Device Name: | LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY |
Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
Applicant | RIM-WIDE COMPANIES, INC. P O BOX 910184 San Diego, CA 92191 -0184 |
Contact | Daniel Hsu |
Correspondent | Daniel Hsu RIM-WIDE COMPANIES, INC. P O BOX 910184 San Diego, CA 92191 -0184 |
Product Code | LYL |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-16 |
Decision Date | 1999-01-13 |
Summary: | summary |