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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 K982558
Device Name BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE
Applicant
BD/PREEFIL
1 BECTON DR. MC 226
FRANKLIN LAKES,  NJ  07417
Applicant Contact GREG MORGAN
Correspondent
BD/PREEFIL
1 BECTON DR. MC 226
FRANKLIN LAKES,  NJ  07417
Correspondent Contact GREG MORGAN
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received07/22/1998
Decision Date 03/08/2000
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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