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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 K011967
Device Name BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE
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 Number880.5200
Classification Product Code
FOZ  
Date Received06/25/2001
Decision Date 01/23/2002
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
Predetermined Change
Control Plan Authorized		 No
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