The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Opti-free Contact Lens Case.
Device ID | K931620 |
510k Number | K931620 |
Device Name: | OPTI-FREE CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Contact | Dean A Knight |
Correspondent | Dean A Knight ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth, TX 76134 -2099 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-02 |
Decision Date | 1993-06-28 |