510(k) K900778

ITEM #272 MAGNIF-EYES CONTACT LENS CASE by Magnivision, Inc. — Product Code LRX

K900778 is an FDA 510(k) premarket notification submitted by Magnivision, Inc. for the device "ITEM #272 MAGNIF-EYES CONTACT LENS CASE". The FDA issued a decision of Substantially Equivalent on March 30, 1990. 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
March 30, 1990
Date Received
February 20, 1990
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