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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K110282
Device Name LIGHTY DD INFUSION SET
Applicant
MEDX-SET LTD
56B SHAWDOW DR.
HUDSON,  NH  03051
Applicant Contact RAYMOND KELLY
Correspondent
MEDX-SET LTD
56B SHAWDOW DR.
HUDSON,  NH  03051
Correspondent Contact RAYMOND KELLY
Regulation Number880.5440
Classification Product Code
FPA  
Date Received01/31/2011
Decision Date 04/27/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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