The following data is part of a premarket notification filed by Lens Comfort, Inc. with the FDA for New Comfort Contact Lens Care Accessory.
Device ID | K962112 |
510k Number | K962112 |
Device Name: | NEW COMFORT CONTACT LENS CARE ACCESSORY |
Classification | Accessories, Solution, Ultrasonic Cleaners For Lenses |
Applicant | LENS COMFORT, INC. 912 BROAD ST. Elizabeth, NJ 07208 |
Contact | James Demestichas |
Correspondent | James Demestichas LENS COMFORT, INC. 912 BROAD ST. Elizabeth, NJ 07208 |
Product Code | LYL |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-31 |
Decision Date | 1996-11-29 |
Summary: | summary |