510(k) K970698

BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS by Polymer Technology Corp. — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 6, 1997
Date Received
February 25, 1997
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