The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Clear Care Plus Cleaning & Disinfectiong Solution With Hydraglyde.
Device ID | K142284 |
510k Number | K142284 |
Device Name: | CLEAR CARE PLUS CLEANING & DISINFECTIONG SOLUTION WITH HYDRAGLYDE |
Classification | Accessories, Soft Lens Products |
Applicant | ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 |
Contact | Alicia Plesnarski |
Correspondent | Alicia Plesnarski ALCON LABORATORIES, INC. 6201 SOUTH FREEWAY Fort Worth, TX 76134 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-08-18 |
Decision Date | 2015-01-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00300650363426 | K142284 | 000 |
00300650363419 | K142284 | 000 |
00300650363402 | K142284 | 000 |
00300650363396 | K142284 | 000 |