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FDA 510(k)

MACKENZIE'S TONSILLECTOME

K-Number: K822186 · 1982-08-25

ApplicantKelleher Corp.
Decision Date1982-08-25
Product CodeKCA
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MACKENZIE'S TONSILLECTOME is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-08-25 under 510(k) number K822186. The device is classified under product code KCA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MACKENZIE'S TONSILLECTOME?

MACKENZIE'S TONSILLECTOME is a medical device that received FDA 510(k) clearance on 1982-08-25. The listed applicant is Kelleher Corp.. The 510(k) number is K822186.

When did MACKENZIE'S TONSILLECTOME receive FDA 510(k) clearance?

MACKENZIE'S TONSILLECTOME received FDA 510(k) clearance on 1982-08-25, under 510(k) number K822186.

Who is the listed applicant for MACKENZIE'S TONSILLECTOME?

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

What is the FDA product code for MACKENZIE'S TONSILLECTOME?

The FDA product code for MACKENZIE'S TONSILLECTOME is KCA.

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Other records listing Kelleher 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.

K822618EMERGENCY TRACHEOSTOMY INSTRUMENT SETK822268NAGASHIMA NS-III ELECTRONYSTAGMOGRAPHK823083ELECTROSURGICAL UNITK822252ENT TREATMENT UNITSK823111NYSTYMOGRAPH ACCESSK822272HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS

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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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