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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K161613
Device Name Hang&Go PAC
Applicant
RanD S.r.l.
via Statale 12, 62
Medolla,  IT 41036
Applicant Contact Simone Ceretti
Correspondent
RanD S.r.l.
via Statale 12, 62
Medolla,  IT 41036
Correspondent Contact Simone Ceretti
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received06/10/2016
Decision Date 12/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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