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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 K141437
Device Name XLR8 PLUS (XLR8+)
Applicant
Genadyne Biotechnologies, Inc.
16 Midland Ave.
Hicksville,  NY  11801
Applicant Contact CHIEN MING, GOH
Correspondent
Genadyne Biotechnologies, Inc.
16 Midland Ave.
Hicksville,  NY  11801
Correspondent Contact CHIEN MING, GOH
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/30/2014
Decision Date 09/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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