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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sponge, ophthalmic
510(k) Number K130117
Device Name NETWORK EYE SPEARS, POINTS, DRAINS, WICKS AND SHIELDS
Applicant
NETWORK MEDICAL PRODUCTS, LTD.
Coronet House, Kearsley Road
Ripon,  GB HG4 2SG
Applicant Contact ALISON MARCH
Correspondent
NETWORK MEDICAL PRODUCTS, LTD.
Coronet House, Kearsley Road
Ripon,  GB HG4 2SG
Correspondent Contact ALISON MARCH
Regulation Number886.4790
Classification Product Code
HOZ  
Date Received01/16/2013
Decision Date 10/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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