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FDA 510(k)

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS

K-Number: K935443 · 1994-09-20

ApplicantOsada Electric Co., Ltd.
Decision Date1994-09-20
Product CodeDZH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Osada Electric Co., Ltd.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K935443. The device is classified under product code DZH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS?

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Osada Electric Co., Ltd.. The 510(k) number is K935443.

When did ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS receive FDA 510(k) clearance?

ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS received FDA 510(k) clearance on 1994-09-20, under 510(k) number K935443.

Who is the listed applicant for ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS?

The FDA 510(k) record lists Osada Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS?

The FDA product code for ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS is DZH.

Related Clinical Trials

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Other records listing Osada Electric Co., Ltd. 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.

K904742OSADA ENDEXK844250OSADA ENAC

Related Devices (Code: DZH)

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.

K031793DENTATUS OSCIOMATDentatus USA , Ltd.K760958SURGICAL OSCILLATING SAWAmerican Safety Equipment Corp.K760957SURGICAL RECIPROCATING SAWAmerican Safety Equipment 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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