510(k) K140488

CONTACT LENS CASE by Maca Plastics, Inc. — Product Code LRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
February 27, 2014
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