FDA 510(k) Application Details - K140352

Device Classification Name Plug, Punctum

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510(K) Number K140352
Device Name Plug, Punctum
Applicant KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS
2500 SANDERSVILLE RD.
LEXINGTON, KY 40511 US
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Contact ARCHNA JOHNSON
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Regulation Number 000.0000

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Classification Product Code LZU
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Date Received 02/12/2014
Decision Date 11/13/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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