The following data is part of a premarket notification filed by Optimum Manufacturers, Inc. with the FDA for Contact Lens Case For Soft Lenses.
Device ID | K840692 |
510k Number | K840692 |
Device Name: | CONTACT LENS CASE FOR SOFT LENSES |
Classification | Case, Contact Lens |
Applicant | OPTIMUM MANUFACTURERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-16 |
Decision Date | 1984-06-07 |