FDA 510(k) Application Details - K130117

Device Classification Name Sponge, Ophthalmic

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510(K) Number K130117
Device Name Sponge, Ophthalmic
Applicant NETWORK MEDICAL PRODUCTS, LTD.
Coronet House, Kearsley Road
Ripon HG4 2SG GB
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Contact ALISON MARCH
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Regulation Number 886.4790

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Classification Product Code HOZ
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Date Received 01/16/2013
Decision Date 10/29/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OP - Ophthalmic
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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