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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 K102659
Device Name MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER
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 Received09/15/2010
Decision Date 12/08/2010
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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