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FDA 510(k)

LUCAE'S EAR & NASAL APPLICATORS

K-Number: K832667 · 1983-09-29

ApplicantKells Medical, Inc.
Decision Date1983-09-29
Product CodeKCJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LUCAE'S EAR & NASAL APPLICATORS is the device name listed in this FDA 510(k) record. The listed applicant is Kells Medical, Inc.. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832667. The device is classified under product code KCJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUCAE'S EAR & NASAL APPLICATORS?

LUCAE'S EAR & NASAL APPLICATORS is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Kells Medical, Inc.. The 510(k) number is K832667.

When did LUCAE'S EAR & NASAL APPLICATORS receive FDA 510(k) clearance?

LUCAE'S EAR & NASAL APPLICATORS received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832667.

Who is the listed applicant for LUCAE'S EAR & NASAL APPLICATORS?

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

What is the FDA product code for LUCAE'S EAR & NASAL APPLICATORS?

The FDA product code for LUCAE'S EAR & NASAL APPLICATORS is KCJ.

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Other records listing Kells Medical, 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.

K926333CPR PLUSK890093PVC EMPTY SOLUTION CONTAINER ENTERAL PUMP SETK890094EVA EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK890095PVC EMPTY SOLUTION CONTAINER W/3 LEAD TRANSFER SETK861972DERMISTRIPK844463DERMIDRESS

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Related Devices (Code: KCJ)

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.

K923679ENDOPATH TISSUE RETAINING COMPONENTEthicon Endo-Surgery, Inc.K921053LAPAROMED LIGATING LOOPLaparomed Corp.K894369APDYNE PHENOL APPLICATOR KITApdyne Medical Co.

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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