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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 K133729
Device Name WOUND DRESSING WITH MANUKA HONEY
Applicant
MANUKA HEALTH NEW ZEALAND LTD.
1011 U.S. HIGHWAY 22
SUITE 200
BRIDGEWATER,  NJ  08807 -2950
Applicant Contact DAVID BECHTEL
Correspondent
MANUKA HEALTH NEW ZEALAND LTD.
1011 U.S. HIGHWAY 22
SUITE 200
BRIDGEWATER,  NJ  08807 -2950
Correspondent Contact DAVID BECHTEL
Classification Product Code
FRO  
Date Received12/06/2013
Decision Date 01/23/2015
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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