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FDA 510(k)

PERFECT ONE

K-Number: K862930 · 1986-10-24

ApplicantNorth American Alloys, Inc.
Decision Date1986-10-24
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERFECT ONE is the device name listed in this FDA 510(k) record. The listed applicant is North American Alloys, Inc.. It received FDA 510(k) clearance on 1986-10-24 under 510(k) number K862930. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERFECT ONE?

PERFECT ONE is a medical device that received FDA 510(k) clearance on 1986-10-24. The listed applicant is North American Alloys, Inc.. The 510(k) number is K862930.

When did PERFECT ONE receive FDA 510(k) clearance?

PERFECT ONE received FDA 510(k) clearance on 1986-10-24, under 510(k) number K862930.

Who is the listed applicant for PERFECT ONE?

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

What is the FDA product code for PERFECT ONE?

The FDA product code for PERFECT ONE is EJH.

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 North American Alloys, 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.

K993344P10 SPECIALK873661CHROME-COBALT BASE DENTAL ALLOYK853845ALLOY BK853498PERFECT 10

Related Devices (Code: EJH)

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.

K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & COK040180CONTINUM VAalba Dent, Inc.K040179CONTINUMAalba Dent, Inc.K033356VERASOFT ESAalba Dent, Inc.K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.K032136WIROBOND CBego U.S.A.

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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