510(k) K882384

DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283 by Magnivision, Inc. — Product Code LRX

K882384 is an FDA 510(k) premarket notification submitted by Magnivision, Inc. for the device "DELUXE CONTACT LENS HOLDER (HARD & SOFT) #283". 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
June 9, 1988
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