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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saline, Vascular Access Flush
510(k) Number K032438
Device Name MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
Applicant
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact DAVID OLSON
Correspondent
TYCO HEALTHCARE
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact DAVID OLSON
Regulation Number880.5200
Classification Product Code
NGT  
Date Received08/07/2003
Decision Date 06/30/2004
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
Recalls CDRH Recalls
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