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510(k) K013556

MONOJECT PREFILL HEPARIN LOCK FLUSH SYRINGE by Tyco Healthcare — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2001
Date Received
October 25, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

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