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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K133934
Device Name MANUKA FOAM HC, MANUKA FOAM HC (WITH ACRYLIC ADHESIVE BORDER), MANUKA FOAM HC (WITH SILICONE ADHESIVE BORDER)
Applicant
Links Medical Products, Inc.
29442 Pt.e Royale
Laguna Niguel,  CA  92677
Applicant Contact James Smith
Correspondent
Links Medical Products, Inc.
29442 Pt.e Royale
Laguna Niguel,  CA  92677
Correspondent Contact James Smith
Classification Product Code
FRO  
Date Received12/23/2013
Decision Date 05/02/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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