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510(k) K140352

VERAPLUG by Krishna Imports Inc Dba Stephens Instruments — Product Code LZU

K140352 is an FDA 510(k) premarket notification submitted by Krishna Imports Inc Dba Stephens Instruments for the device "VERAPLUG". The FDA issued a decision of Substantially Equivalent on November 13, 2014. The device falls under product code LZU (Plug, Punctum), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2014
Date Received
February 12, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plug, Punctum
Device Class
Class U
Regulation Number
Review Panel
OP
Submission Type

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FDA data resources