The following data is part of a premarket notification filed by Wesley Jessen Corp. with the FDA for W-j Sterile Tri-functional Contact Lens Solution.
Device ID | K872973 |
510k Number | K872973 |
Device Name: | W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION |
Classification | Accessories, Soft Lens Products |
Applicant | WESLEY JESSEN CORP. 400 WEST SUPERIOR ST. Chicago, IL 60610 |
Contact | David M Patino |
Correspondent | David M Patino WESLEY JESSEN CORP. 400 WEST SUPERIOR ST. Chicago, IL 60610 |
Product Code | LPN |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-30 |
Decision Date | 1987-10-15 |