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FDA 510(k)

TYMPANOPLASTY & SKIN DISSECTORS

K-Number: K822569 · 1982-10-06

ApplicantKelleher Corp.
Decision Date1982-10-06
Product CodeGDI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TYMPANOPLASTY & SKIN DISSECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Kelleher Corp.. It received FDA 510(k) clearance on 1982-10-06 under 510(k) number K822569. The device is classified under product code GDI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYMPANOPLASTY & SKIN DISSECTORS?

TYMPANOPLASTY & SKIN DISSECTORS is a medical device that received FDA 510(k) clearance on 1982-10-06. The listed applicant is Kelleher Corp.. The 510(k) number is K822569.

When did TYMPANOPLASTY & SKIN DISSECTORS receive FDA 510(k) clearance?

TYMPANOPLASTY & SKIN DISSECTORS received FDA 510(k) clearance on 1982-10-06, under 510(k) number K822569.

Who is the listed applicant for TYMPANOPLASTY & SKIN DISSECTORS?

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 TYMPANOPLASTY & SKIN DISSECTORS?

The FDA product code for TYMPANOPLASTY & SKIN DISSECTORS is GDI.

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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: GDI)

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.

K896383DISPOSABLE EXTERNAL CLAMPSGalenica Enterprises, Inc.K850288HEPATIC PARENCHYMAL SUCTION DISSECTORBeecher Medical Diagnostic InstrumentationK831912ROUND-BEEHIVE- DISSECTORS 3/8Ormed Mfg., Inc.K803292FIELD SUCTION DISSECTORV. Mueller O.V. Baxter Healthcare Corp.K791870DISPOSABLE SPECIALITY SPONGESCarwild Corp.K791703TEW BYPASS INSTRUMENTS & DISSECTING KITEdward Weck, 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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