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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K172010
Device Name gel-e Bandage
Applicant
Gel-E, Inc. (Formerly Remedium Technologies, Inc.)
387 Technology Dr., Suite 3110b
College Park,  MD  20742
Applicant Contact Matthew Dowling
Correspondent
Cyngus Regulatory
Cincinnati,  OH  45226
Correspondent Contact Elsa Abruzzo
Classification Product Code
KGN  
Date Received07/03/2017
Decision Date 12/07/2017
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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