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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 K833949
Device Name MICRO INFUSION SET
Original Applicant
DELTEC SYSTEMS, INC.
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/15/1983
Decision Date 01/11/1984
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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