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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K884463
Device Name CONNECTA MONOFLO & MULTIFLO INFUSION CONNECTORS
Applicant
OHMEDA MEDICAL
2007 PAN AM CIRCLE
TAMPA,  FL  33702
Applicant Contact JILL PHILLIPS
Correspondent
OHMEDA MEDICAL
2007 PAN AM CIRCLE
TAMPA,  FL  33702
Correspondent Contact JILL PHILLIPS
Regulation Number880.5440
Classification Product Code
FMG  
Date Received10/24/1988
Decision Date 01/09/1989
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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