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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K161615
Device Name Accurett
Applicant
H&O Equipments, Nv/Sa
Rue Des Journaliers 1
Ghislenghien,  BE 7822
Applicant Contact Aline Franck
Correspondent
Qserve Group, Us, Inc.
5600 Wisconsin Ave., # 509
Chevy Chase,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number878.4350
Classification Product Code
GEH  
Date Received06/10/2016
Decision Date 08/23/2016
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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