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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 K101114
Device Name ADVANCIS ACTIVON TUBE
Applicant
Advancis Medical
Sidings Rd., Lowmoor Industrial Estate
Kirby In Ashfield,  GB NG17 7JZ
Applicant Contact Toni Miller
Correspondent
Lec Associates, LLC
26 Chesnut Ridge Rd., #12
Montvale,  NJ  07645
Correspondent Contact Toni Miller
Classification Product Code
FRO  
Date Received04/21/2010
Decision Date 07/26/2011
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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