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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K171148
Device Name Aleo BME Liquid Bandage
Applicant
Aleo Bme, Inc.
200 Innovations Blvd., Suite 210a
State College,  PA  16803
Applicant Contact Chao Liu
Correspondent
Msquared Associates, Inc.
575 Eighth Ave.
Suite 1212
New York,  NY  10018
Correspondent Contact LeAnn Latham
Regulation Number880.5090
Classification Product Code
KMF  
Date Received04/19/2017
Decision Date 01/12/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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