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FDA 510(k)

MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL

K-Number: K020999 · 2002-06-20

ApplicantMedefil, Inc.
Decision Date2002-06-20
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL is the device name listed in this FDA 510(k) record. The listed applicant is Medefil, Inc.. It received FDA 510(k) clearance on 2002-06-20 under 510(k) number K020999. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL?

MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL is a medical device that received FDA 510(k) clearance on 2002-06-20. The listed applicant is Medefil, Inc.. The 510(k) number is K020999.

When did MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL receive FDA 510(k) clearance?

MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL received FDA 510(k) clearance on 2002-06-20, under 510(k) number K020999.

Who is the listed applicant for MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL?

The FDA 510(k) record lists Medefil, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL?

The FDA product code for MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL is NGT.

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Other records listing Medefil, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121262MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READYK092491MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZESK091583MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGEK020996MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LLK993518MEDEFIL'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 LLK993515MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L

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Related Devices (Code: NGT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and CompanyK233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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