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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K011982
Device Name 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
Applicant
BD
ONE BECTON DRIVE MC226
FRANKLIN LAKES,  NJ  07417
Applicant Contact GREGORY W MORGAN
Correspondent
BD
ONE BECTON DRIVE MC226
FRANKLIN LAKES,  NJ  07417
Correspondent Contact GREGORY W MORGAN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/26/2001
Decision Date 07/17/2001
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
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