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FDA 510(k)

THE DENVER SPLINT

K-Number: K791053 · 1979-08-16

ApplicantRonald D. Shippert, M.D.
Decision Date1979-08-16
Product CodeEPP
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

THE DENVER SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Ronald D. Shippert, M.D.. It received FDA 510(k) clearance on 1979-08-16 under 510(k) number K791053. The device is classified under product code EPP. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DENVER SPLINT?

THE DENVER SPLINT is a medical device that received FDA 510(k) clearance on 1979-08-16. The listed applicant is Ronald D. Shippert, M.D.. The 510(k) number is K791053.

When did THE DENVER SPLINT receive FDA 510(k) clearance?

THE DENVER SPLINT received FDA 510(k) clearance on 1979-08-16, under 510(k) number K791053.

Who is the listed applicant for THE DENVER SPLINT?

The FDA 510(k) record lists Ronald D. Shippert, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE DENVER SPLINT?

The FDA product code for THE DENVER SPLINT is EPP.

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

Related Devices (Code: EPP)

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.

K942158AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITSWfr/Aquaplast Corp.K942724EXTERNAL NASAL SPLINTMicromed Development Corp.K895502MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINTMicrobio-Medics, Inc.K890599HOOD NASAL SPLINTHood LaboratoriesK882244RICHARDS THERMOPLASTIC DORSAL NASAL SPLINTRichards Medical Co., Inc.K872905AMERICAN NASAL SPONGEAmerican Silk Sutures, Inc.

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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