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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K180152
Device Name gel-e Flex
Applicant
Gel-E, Inc.
387 Technology Dr., Suite 3110b
College Park,  MD  20742
Applicant Contact Elsa Abruzzo
Correspondent
Gel-E, Inc.
387 Technology Dr., Suite 3110b
College Park,  MD  20742
Correspondent Contact Elsa Abruzzo
Classification Product Code
QSY  
Date Received01/19/2018
Decision Date 06/22/2018
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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