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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K093406
Device Name MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519
Applicant
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Applicant Contact JODI LYNN FRASIER
Correspondent
ANGIODYNAMICS, INC.
603 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Correspondent Contact JODI LYNN FRASIER
Regulation Number880.5970
Classification Product Code
LJS  
Date Received11/02/2009
Decision Date 03/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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