FDA 510(k) Application Details - K113316

Device Classification Name Lacrimal Stents And Intubation Sets

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510(K) Number K113316
Device Name Lacrimal Stents And Intubation Sets
Applicant DCS SURGICAL INC
1110 LINDEN AVE.
BOULDER, CO 80304 US
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Contact HARRY ROSS
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Regulation Number 000.0000

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Classification Product Code OKS
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Date Received 11/09/2011
Decision Date 11/08/2012
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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