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FDA 510(k)

SHEA'S EAR SPECULUM HOLDER PORT MANNS

K-Number: K822011 · 1982-08-12

ApplicantKelleher Corp.
Decision Date1982-08-12
Product CodeJYK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SHEA'S EAR SPECULUM HOLDER PORT MANNS is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-08-12 under 510(k) number K822011. The device is classified under product code JYK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEA'S EAR SPECULUM HOLDER PORT MANNS?

SHEA'S EAR SPECULUM HOLDER PORT MANNS is a medical device that received FDA 510(k) clearance on 1982-08-12. The listed applicant is Kelleher Corp.. The 510(k) number is K822011.

When did SHEA'S EAR SPECULUM HOLDER PORT MANNS receive FDA 510(k) clearance?

SHEA'S EAR SPECULUM HOLDER PORT MANNS received FDA 510(k) clearance on 1982-08-12, under 510(k) number K822011.

Who is the listed applicant for SHEA'S EAR SPECULUM HOLDER PORT MANNS?

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 SHEA'S EAR SPECULUM HOLDER PORT MANNS?

The FDA product code for SHEA'S EAR SPECULUM HOLDER PORT MANNS is JYK.

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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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