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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, Short-Term Less Than 30 Days
510(k) Number K042504
Device Name CATHY STERILE DISPOSABLE I.V. CANNULA WITH CATHETER
Applicant
MYCO MEDICAL SUPPLIES, INC.
113 CENTRE WEST COURT
CARY,  NC  27513
Applicant Contact SANJIV KUMAR
Correspondent
MYCO MEDICAL SUPPLIES, INC.
113 CENTRE WEST COURT
CARY,  NC  27513
Correspondent Contact SANJIV KUMAR
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/15/2004
Decision Date 01/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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