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FDA 510(k)

SYRINGE ADDITIVE IV ADMIN. SETS

K-Number: K841361 · 1984-05-21

ApplicantQuest Medical, Inc.
Decision Date1984-05-21
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGE ADDITIVE IV ADMIN. SETS is the device name listed in this FDA 510(k) record. The listed applicant is Quest Medical, Inc.. It received FDA 510(k) clearance on 1984-05-21 under 510(k) number K841361. 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 SYRINGE ADDITIVE IV ADMIN. SETS?

SYRINGE ADDITIVE IV ADMIN. SETS is a medical device that received FDA 510(k) clearance on 1984-05-21. The listed applicant is Quest Medical, Inc.. The 510(k) number is K841361.

When did SYRINGE ADDITIVE IV ADMIN. SETS receive FDA 510(k) clearance?

SYRINGE ADDITIVE IV ADMIN. SETS received FDA 510(k) clearance on 1984-05-21, under 510(k) number K841361.

Who is the listed applicant for SYRINGE ADDITIVE IV ADMIN. SETS?

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

What is the FDA product code for SYRINGE ADDITIVE IV ADMIN. SETS?

The FDA product code for SYRINGE ADDITIVE IV ADMIN. SETS is FPA.

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Other records listing Quest Medical, Inc. as applicant

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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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