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510(k) K993518

MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL by Medefil, Inc. — Product Code FOZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 12, 2000
Date Received: October 18, 1999
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

Other clearances by Medefil, Inc.

K121262 — MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY (September 20, 2012)
K092491 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN (February 3, 2010)
K091583 — MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE (January 28, 2010)
K020996 — MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML S (June 24, 2002)
K020999 — MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML (June 20, 2002)
K993515 — MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML (February 25, 2000)

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