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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
Device Name PROTECTOR, INJECTOR, CONNECTOR
Original Applicant
BD MEDICAL-MEDICAL SURGICAL SYSTEMS
1 becton drive
franklin lakes,  NJ  07417
Original Contact john roberts
Regulation Number880.5440
Classification Product Code
LHI  
Date Received02/07/2012
Decision Date 09/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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