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FDA 510(k)

ISOSTATIC CONDENSER

K-Number: K843901 · 1984-12-03

ApplicantShofu Dental Corp.
Decision Date1984-12-03
Product CodeEKG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ISOSTATIC CONDENSER is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1984-12-03 under 510(k) number K843901. The device is classified under product code EKG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOSTATIC CONDENSER?

ISOSTATIC CONDENSER is a medical device that received FDA 510(k) clearance on 1984-12-03. The listed applicant is Shofu Dental Corp.. The 510(k) number is K843901.

When did ISOSTATIC CONDENSER receive FDA 510(k) clearance?

ISOSTATIC CONDENSER received FDA 510(k) clearance on 1984-12-03, under 510(k) number K843901.

Who is the listed applicant for ISOSTATIC CONDENSER?

The FDA 510(k) record lists Shofu Dental Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOSTATIC CONDENSER?

The FDA product code for ISOSTATIC CONDENSER is EKG.

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Other records listing Shofu Dental Corp. as applicant

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Related Devices (Code: EKG)

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.

K865025AUSTENAL CONDENSING INSTRUMENTAustenal Dental, Inc.K823322DENTAL INSTRUMENTS - PLUGGERSMiltex, 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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