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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 K081156
Device Name CADD MEDICATION CASSETTE RESERVOIR
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Applicant Contact DAVID H SHORT
Correspondent
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL,  MN  55112
Correspondent Contact DAVID H SHORT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received04/23/2008
Decision Date 07/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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