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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 K842143
Device Name BENT WINGED MINI-VOL INFUSION SET
Applicant
MEDFUSION SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MEDFUSION SYSTEMS, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number880.5440
Classification Product Code
FPA  
Date Received05/30/1984
Decision Date 07/20/1984
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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