510(k) K923458

CONTACT LENS CASE by Nomax, Inc. — Product Code LRX

K923458 is an FDA 510(k) premarket notification submitted by Nomax, Inc. for the device "CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on May 12, 1993. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1993
Date Received
July 14, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Case, Contact Lens
Device Class
Class II
Regulation Number
886.5928
Review Panel
OP
Submission Type