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FDA 510(k)

EAR SPECULI

K-Number: K822164 · 1982-08-11

ApplicantKelleher Corp.
Decision Date1982-08-11
Product CodeEPY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EAR SPECULI is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-08-11 under 510(k) number K822164. The device is classified under product code EPY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EAR SPECULI?

EAR SPECULI is a medical device that received FDA 510(k) clearance on 1982-08-11. The listed applicant is Kelleher Corp.. The 510(k) number is K822164.

When did EAR SPECULI receive FDA 510(k) clearance?

EAR SPECULI received FDA 510(k) clearance on 1982-08-11, under 510(k) number K822164.

Who is the listed applicant for EAR SPECULI?

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 EAR SPECULI?

The FDA product code for EAR SPECULI is EPY.

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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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Related Devices (Code: EPY)

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.

K950086PEDIA PALS, INCORPORATEDPedia Pals, Inc.K925754ECONOMRudolf Riester GmbH & Co. KGK853588FIBRELIGHT NASAL SPECULADowns Surgical , Ltd.K834189JAKOBI SURG. INSTRUMENTS #7 44/47Imm Enterprises , Ltd.K822373EAR SURGERY SPECULUMTreace Medical, Inc.K822370UNIVERSAL SPECULUM HOLDERTreace Medical, 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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