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FDA 510(k)

PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS

K-Number: K972527 · 1997-09-18

ApplicantQuality System Consulting
Decision Date1997-09-18
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Quality System Consulting. It received FDA 510(k) clearance on 1997-09-18 under 510(k) number K972527. 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 PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS?

PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS is a medical device that received FDA 510(k) clearance on 1997-09-18. The listed applicant is Quality System Consulting. The 510(k) number is K972527.

When did PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS receive FDA 510(k) clearance?

PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS received FDA 510(k) clearance on 1997-09-18, under 510(k) number K972527.

Who is the listed applicant for PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS?

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

What is the FDA product code for PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS?

The FDA product code for PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS is FPA.

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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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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