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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 K011858
Device Name INTERLINK THREADED LOCK CANNULA
Applicant
Bd
1 Becton Dr. Mc226
Franklin Lakes,  NJ  07417
Applicant Contact GREGORY W MORGAN
Correspondent
Bd
1 Becton Dr. Mc226
Franklin Lakes,  NJ  07417
Correspondent Contact GREGORY W MORGAN
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMI  
Date Received06/14/2001
Decision Date 06/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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