The following data is part of a premarket notification filed by Nomax, Inc. with the FDA for Contact Lens Case.
Device ID | K923458 |
510k Number | K923458 |
Device Name: | CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | NOMAX, INC. 31 SCUDDER RD. Sparta, NJ 07871 |
Contact | Andrea Friedman |
Correspondent | Andrea Friedman NOMAX, INC. 31 SCUDDER RD. Sparta, NJ 07871 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-14 |
Decision Date | 1993-05-12 |