510(k) K960584

NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY by Novavision, Inc. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1996
Date Received
February 12, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Other Material) - Daily
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type