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FDA 510(k)

MEDEFOAM-2

K-Number: K800840 · 1980-06-17

ApplicantMedefield Pty. , Ltd.
Decision Date1980-06-17
Product CodeKTA
DecisionSubstantially Equivalent

Device Summary

MEDEFOAM-2 is the device name listed in this FDA 510(k) record. The listed applicant is Medefield Pty. , Ltd.. It received FDA 510(k) clearance on 1980-06-17 under 510(k) number K800840. The device is classified under product code KTA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDEFOAM-2?

MEDEFOAM-2 is a medical device that received FDA 510(k) clearance on 1980-06-17. The listed applicant is Medefield Pty. , Ltd.. The 510(k) number is K800840.

When did MEDEFOAM-2 receive FDA 510(k) clearance?

MEDEFOAM-2 received FDA 510(k) clearance on 1980-06-17, under 510(k) number K800840.

Who is the listed applicant for MEDEFOAM-2?

The FDA 510(k) record lists Medefield Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDEFOAM-2?

The FDA product code for MEDEFOAM-2 is KTA.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medefield Pty. , Ltd. 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.

K800843MEDEFIZZ A & MEDEFIZZ BK800839MEDESCANK800841MEDEBAR MK800842MEDEBAR XAC-90K800844MEDEBAR XL

Related Devices (Code: KTA)

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.

K800843MEDEFIZZ A & MEDEFIZZ BMedefield Pty. , Ltd.K800839MEDESCANMedefield Pty. , Ltd.K800841MEDEBAR MMedefield Pty. , Ltd.K800844MEDEBAR XLMedefield Pty. , Ltd.K800842MEDEBAR XAC-90Medefield Pty. , Ltd.K800459BARIUM SULFATE, USP IN SUSPENSIONCentral Pharmaceuticals, Inc.

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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