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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K000367
Device Name SECURMIX
Applicant
Eurospital
15 Oak St.
Beverly,  MA  01915
Applicant Contact FRAN WHITE
Correspondent
Eurospital
15 Oak St.
Beverly,  MA  01915
Correspondent Contact FRAN WHITE
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/04/2000
Decision Date 02/29/2000
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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