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FDA 510(k)

CONTROL SYRINGE

K-Number: K801430 · 1980-07-08

ApplicantAbco Dealers, Inc.
Decision Date1980-07-08
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CONTROL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Abco Dealers, Inc.. It received FDA 510(k) clearance on 1980-07-08 under 510(k) number K801430. 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 CONTROL SYRINGE?

CONTROL SYRINGE is a medical device that received FDA 510(k) clearance on 1980-07-08. The listed applicant is Abco Dealers, Inc.. The 510(k) number is K801430.

When did CONTROL SYRINGE receive FDA 510(k) clearance?

CONTROL SYRINGE received FDA 510(k) clearance on 1980-07-08, under 510(k) number K801430.

Who is the listed applicant for CONTROL SYRINGE?

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

What is the FDA product code for CONTROL SYRINGE?

The FDA product code for CONTROL SYRINGE is FMF.

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Other records listing Abco Dealers, 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.

K905025DIGITAL THERMOMETER KITSK882304DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL)K880892BLOOD COLLECTING NEEDLE AND HOLDERSK880894ALLERGIST SYRINGESK872875STRETCH GAUZE BANDAGESK872874MICROSCOPE COVER GLASSES

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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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