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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, i.v. fluid transfer
510(K) Number K120384
Models C100, C35, C45, C50, C60, C61, C70, C80, N30, N30C, N35, N35C, P14, P21, P28, P50, P53
Device Name PROTECTOR, INJECTOR, CONNECTOR
Applicant
BD MEDICAL-MEDICAL SURGICAL SYSTEMS
1 becton drive
franklin lakes,  NJ  07417
Contact john roberts
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/07/2012
Decision Date 09/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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