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FDA 510(k)

MOUTH GAGS

K-Number: K822183 · 1982-08-16

ApplicantKelleher Corp.
Decision Date1982-08-16
Product CodeKBN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MOUTH GAGS is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822183. The device is classified under product code KBN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOUTH GAGS?

MOUTH GAGS is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Kelleher Corp.. The 510(k) number is K822183.

When did MOUTH GAGS receive FDA 510(k) clearance?

MOUTH GAGS received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822183.

Who is the listed applicant for MOUTH GAGS?

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 MOUTH GAGS?

The FDA product code for MOUTH GAGS is KBN.

Related Clinical Trials

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.

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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

View all 94 devices →

Related Devices (Code: KBN)

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.

K834540OP-CON SURGICAL INSTRUMENT #9Imm Enterprises , Ltd.K780992MILLARD MOUTH GAGNestor Engineering Associates, 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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