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FDA 510(k)

UNITEK CONVERTIBLE CAP REMOVER TOOL

K-Number: K843742 · 1984-11-09

ApplicantUnitek Corp.
Decision Date1984-11-09
Product CodeJEX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNITEK CONVERTIBLE CAP REMOVER TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Unitek Corp.. It received FDA 510(k) clearance on 1984-11-09 under 510(k) number K843742. The device is classified under product code JEX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNITEK CONVERTIBLE CAP REMOVER TOOL?

UNITEK CONVERTIBLE CAP REMOVER TOOL is a medical device that received FDA 510(k) clearance on 1984-11-09. The listed applicant is Unitek Corp.. The 510(k) number is K843742.

When did UNITEK CONVERTIBLE CAP REMOVER TOOL receive FDA 510(k) clearance?

UNITEK CONVERTIBLE CAP REMOVER TOOL received FDA 510(k) clearance on 1984-11-09, under 510(k) number K843742.

Who is the listed applicant for UNITEK CONVERTIBLE CAP REMOVER TOOL?

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

What is the FDA product code for UNITEK CONVERTIBLE CAP REMOVER TOOL?

The FDA product code for UNITEK CONVERTIBLE CAP REMOVER TOOL is JEX.

Related Clinical Trials

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Other records listing Unitek Corp. 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.

K944286METAL-LINED TRANSCEND CERAMIC BRACKETK933501ALASTIKK940165ALASTIKK923999ALASTIK NSK924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSK924295DEBRACKETING INSTRUMENT

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Related Devices (Code: JEX)

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.

K955242TITANIUM BIRD BEAK PLIERSybron Dental Specialties, Inc.K935141DENTAURUM PLIERSDentauraum, Inc.K924645TRANSCEND SERIES 6000 DEBONDING INSTRUMENTSUnitek Corp.K924295DEBRACKETING INSTRUMENTUnitek Corp.K854088UNITEK LIFT-OFF DEBRACKETING INSTRUMENTUnitex Corp.K760984ORTHODONTIC INSTRUMENTSAdp Intl., 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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