510(k) K923458
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