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510(k) K183175

BostonSight Scleral by Bostonsight — Product Code HQD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2019
Date Received
November 16, 2018
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

Other clearances by Bostonsight

  • K161461 — BostonSight PD Prosthetic Device (July 25, 2016)

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