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FDA 510(k)

GAINOR MEDICAL SYRINGE

K-Number: K844306 · 1984-11-30

ApplicantGainor Medical
Decision Date1984-11-30
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GAINOR MEDICAL SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical. It received FDA 510(k) clearance on 1984-11-30 under 510(k) number K844306. 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 GAINOR MEDICAL SYRINGE?

GAINOR MEDICAL SYRINGE is a medical device that received FDA 510(k) clearance on 1984-11-30. The listed applicant is Gainor Medical. The 510(k) number is K844306.

When did GAINOR MEDICAL SYRINGE receive FDA 510(k) clearance?

GAINOR MEDICAL SYRINGE received FDA 510(k) clearance on 1984-11-30, under 510(k) number K844306.

Who is the listed applicant for GAINOR MEDICAL SYRINGE?

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

What is the FDA product code for GAINOR MEDICAL SYRINGE?

The FDA product code for GAINOR MEDICAL SYRINGE is FMF.

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Other records listing Gainor Medical 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.

K850100BLOOD LANCETK850150ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MEDK844305GAINOR MEDICAL FLOWMAX NEEDLESK840945SKIN CLOSUREK840951FIRST AID BANDAGEK840950ZINC OXIDE TAPE

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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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