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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K142646
FOIA Releasable 510(k) K142646
Device Name XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and
Applicant
Genadyne Biotechnologies, Inc.
16 Midland Ave.
Hicksville,  NY  11801
Applicant Contact Chien Ming
Correspondent
Genadyne Biotechnologies, Inc.
16 Midland Ave.
Hicksville,  NY  11801
Correspondent Contact Chien Ming
Regulation Number878.4780
Classification Product Code
OMP  
Date Received09/17/2014
Decision Date 04/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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