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510(k) K142715

Sensor Medical Family of Vitrectomy Lenses and Products by Sensor Medical Technology, LLC — Product Code HJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 2014
Date Received
September 22, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, Polymethylmethacrylate, Diagnostic
Device Class
Class II
Regulation Number
886.1385
Review Panel
OP
Submission Type

Other clearances by Sensor Medical Technology, LLC

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  • K140368 — FAMILY OF DISPOSABLE LENSES (April 29, 2014)

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