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FDA 510(k)

ULTICARE DISPOSABLE SYRINGES AND NEEDLES

K-Number: K062702 · 2006-11-29

ApplicantUltimed, Inc.
Decision Date2006-11-29
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULTICARE DISPOSABLE SYRINGES AND NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Ultimed, Inc.. It received FDA 510(k) clearance on 2006-11-29 under 510(k) number K062702. 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 ULTICARE DISPOSABLE SYRINGES AND NEEDLES?

ULTICARE DISPOSABLE SYRINGES AND NEEDLES is a medical device that received FDA 510(k) clearance on 2006-11-29. The listed applicant is Ultimed, Inc.. The 510(k) number is K062702.

When did ULTICARE DISPOSABLE SYRINGES AND NEEDLES receive FDA 510(k) clearance?

ULTICARE DISPOSABLE SYRINGES AND NEEDLES received FDA 510(k) clearance on 2006-11-29, under 510(k) number K062702.

Who is the listed applicant for ULTICARE DISPOSABLE SYRINGES AND NEEDLES?

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

What is the FDA product code for ULTICARE DISPOSABLE SYRINGES AND NEEDLES?

The FDA product code for ULTICARE DISPOSABLE SYRINGES AND NEEDLES is FMF.

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Other records listing Ultimed, 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.

K100812ULTICARE DISPOSABLE PEN NEEDLESK080600ULTIMED ULTICARE SAFETY SYRINGEK081449ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTAINERK050464ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2K033794ULTICARE DISPOSABLE SYRINGE 3 ML/CCK021983ULTI GUARD HOME INSULIN SYRINGE CONTAINER

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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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