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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 K110042
Device Name MANUKATEX
Applicant
Manuka Medical Limited
29442 Pt.e Royale
Laguna Niguel,  CA  92677
Applicant Contact James Smith
Correspondent
Manuka Medical Limited
29442 Pt.e Royale
Laguna Niguel,  CA  92677
Correspondent Contact James Smith
Classification Product Code
FRO  
Date Received01/06/2011
Decision Date 03/24/2011
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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