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FDA 510(k)

UNIVEC TWO PIECE SYRINGE

K-Number: K000747 · 2000-06-08

ApplicantUnivec, Inc.
Decision Date2000-06-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

UNIVEC TWO PIECE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Univec, Inc.. It received FDA 510(k) clearance on 2000-06-08 under 510(k) number K000747. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVEC TWO PIECE SYRINGE?

UNIVEC TWO PIECE SYRINGE is a medical device that received FDA 510(k) clearance on 2000-06-08. The listed applicant is Univec, Inc.. The 510(k) number is K000747.

When did UNIVEC TWO PIECE SYRINGE receive FDA 510(k) clearance?

UNIVEC TWO PIECE SYRINGE received FDA 510(k) clearance on 2000-06-08, under 510(k) number K000747.

Who is the listed applicant for UNIVEC TWO PIECE SYRINGE?

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

What is the FDA product code for UNIVEC TWO PIECE SYRINGE?

The FDA product code for UNIVEC TWO PIECE SYRINGE is FMF.

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Other records listing Univec, 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.

K020500UNIVEC BIFURCATED SLIDING SHEATH SYRINGEK993996UNIVEC AUTO-DISABLE HYPODERMIC SYRINGEK961877PISTON SYRINGEK933469UNIVEC NON-REUSABLE SYRINGEK951619UNIVEC NONREUSABLE LOCKING SYRINGEK943679UNIVEC NONRESUSABLE LOCKING SYRINGE

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Related Devices (Code: FMF)

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.

K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLCK252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc.K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., 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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