FDA 510(k) Application Details - K150288

Device Classification Name Plug, Punctum

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510(K) Number K150288
Device Name Plug, Punctum
Applicant RIVERPOINT MEDICAL
825 NE 25th Avenue
Portland, OR 97232 US
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Contact Edwin Anderson
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Regulation Number 000.0000

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Classification Product Code LZU
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Date Received 02/05/2015
Decision Date 08/28/2015
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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