510(k) K890533

ITEM #352/#CS352* CONTACT LENS CASES by Magnivision, Inc. — Product Code LRX

K890533 is an FDA 510(k) premarket notification submitted by Magnivision, Inc. for the device "ITEM #352/#CS352* CONTACT LENS CASES". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Magnivision, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
February 2, 1989
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