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 |