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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Electric For Gravity Flow Infusion Systems
510(k) Number K903193
Device Name SMITH & NEPHEW DYONICS LEVELERT SYSTEM
Applicant
SMITH & NEPHEW DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Applicant Contact ERIC BANNON
Correspondent
SMITH & NEPHEW DYONICS, INC.
160 DASCOMB RD.
ANDOVER,  MA  01810
Correspondent Contact ERIC BANNON
Regulation Number880.2420
Classification Product Code
FLN  
Date Received07/19/1990
Decision Date 08/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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