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FDA 510(k)

STERILE DISP. BUTTERFLY INFUSION SET

K-Number: K832104 · 1983-09-12

ApplicantLee Medical Intl., Inc.
Decision Date1983-09-12
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STERILE DISP. BUTTERFLY INFUSION SET is the device name listed in this FDA 510(k) record. The listed applicant is Lee Medical Intl., Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832104. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERILE DISP. BUTTERFLY INFUSION SET?

STERILE DISP. BUTTERFLY INFUSION SET is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Lee Medical Intl., Inc.. The 510(k) number is K832104.

When did STERILE DISP. BUTTERFLY INFUSION SET receive FDA 510(k) clearance?

STERILE DISP. BUTTERFLY INFUSION SET received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832104.

Who is the listed applicant for STERILE DISP. BUTTERFLY INFUSION SET?

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

What is the FDA product code for STERILE DISP. BUTTERFLY INFUSION SET?

The FDA product code for STERILE DISP. BUTTERFLY INFUSION SET is FPA.

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Other records listing Lee Medical Intl., 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.

K840082STERILE INSULIN DISPOS. NEEDLE/SYRINGEK840081IV ADMINISTRATION SETK840083STERILE INSULIN DISPOS. NEEDLE/GREENK832105ADMINISTRATIVE IV SETK832101STERILE DISPOSABLE SYRINGEK832102STERILE DISPOSABLE NEEDLES

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Related Devices (Code: FPA)

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.

K254123Ecomed Disposable Administration SetsEcomed Solutions, LLCK261530iiSure Infusion SetDeka Research and DevelopmentK252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)Amsino International, Inc.K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc.K251257nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727]Np MedicalK250325BD Alaris Pump Infusion SetCarefusion (Bd)

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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