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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 K895481
Device Name SHAMROCK SAFETY WINGED INFUSION SET
Applicant
RYAN MEDICAL, INC.
7106 CROSSROADS BLVD. SUITE
201
BRENTWOOD,  TN  37027
Applicant Contact JAMES M KAISER
Correspondent
RYAN MEDICAL, INC.
7106 CROSSROADS BLVD. SUITE
201
BRENTWOOD,  TN  37027
Correspondent Contact JAMES M KAISER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/11/1989
Decision Date 10/10/1989
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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