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FDA 510(k)

KLEIN HANDLE

K-Number: K881783 · 1988-12-02

ApplicantE.L. Medico Intl., Inc.
Decision Date1988-12-02
Product CodeGDM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KLEIN HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is E.L. Medico Intl., Inc.. It received FDA 510(k) clearance on 1988-12-02 under 510(k) number K881783. The device is classified under product code GDM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KLEIN HANDLE?

KLEIN HANDLE is a medical device that received FDA 510(k) clearance on 1988-12-02. The listed applicant is E.L. Medico Intl., Inc.. The 510(k) number is K881783.

When did KLEIN HANDLE receive FDA 510(k) clearance?

KLEIN HANDLE received FDA 510(k) clearance on 1988-12-02, under 510(k) number K881783.

Who is the listed applicant for KLEIN HANDLE?

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

What is the FDA product code for KLEIN HANDLE?

The FDA product code for KLEIN HANDLE is GDM.

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 E.L. Medico 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.

K881784KLEIN NEEDLE

Related Devices (Code: GDM)

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.

K071732MARROWMINERStemcor Systems, Inc.K971114BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K953082ILIAC CREST BONE MARROW ASPIRATION NEEDLEBaxter Healthcare CorpK953064BIOACCESS MARROW HARVEST SYSTEMBioaccess, Inc.K936207ENDO-NEEDLE INSTRUMENTGerard Medical, Inc.K930160ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLESymbiosis Corp.

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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