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FDA 510(k)

MICROETCHER AP

K-Number: K970589 · 1997-09-17

ApplicantDanville Engineering, Inc.
Decision Date1997-09-17
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICROETCHER AP is the device name listed in this FDA 510(k) record. The listed applicant is Danville Engineering, Inc.. It received FDA 510(k) clearance on 1997-09-17 under 510(k) number K970589. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROETCHER AP?

MICROETCHER AP is a medical device that received FDA 510(k) clearance on 1997-09-17. The listed applicant is Danville Engineering, Inc.. The 510(k) number is K970589.

When did MICROETCHER AP receive FDA 510(k) clearance?

MICROETCHER AP received FDA 510(k) clearance on 1997-09-17, under 510(k) number K970589.

Who is the listed applicant for MICROETCHER AP?

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

What is the FDA product code for MICROETCHER AP?

The FDA product code for MICROETCHER AP is KOJ.

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 Danville Engineering, 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.

K955445CARIES FINDERK953504MICROPRIMEK902836MICROETCHER

Related Devices (Code: KOJ)

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.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbHK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, 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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