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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 K120976
Device Name MANUKA IG
Original Applicant
29442 pointe royale
laguna niguel,  CA  92677
Original Contact james smith
Classification Product Code
Date Received04/02/2012
Decision Date 05/23/2012
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes