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510(k) K153066

BostonSight IC Corneal Lens, BostonSight IC Scleral Lens by Boston Foundation For Sight — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2016
Date Received
October 22, 2015
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

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