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FDA 510(k)

XOMED THERMAL MYRINGOTOMY SYSTEM

K-Number: K820157 · 1982-03-02

ApplicantXomed, Inc.
Decision Date1982-03-02
Product CodeHQP
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

XOMED THERMAL MYRINGOTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1982-03-02 under 510(k) number K820157. The device is classified under product code HQP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XOMED THERMAL MYRINGOTOMY SYSTEM?

XOMED THERMAL MYRINGOTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1982-03-02. The listed applicant is Xomed, Inc.. The 510(k) number is K820157.

When did XOMED THERMAL MYRINGOTOMY SYSTEM receive FDA 510(k) clearance?

XOMED THERMAL MYRINGOTOMY SYSTEM received FDA 510(k) clearance on 1982-03-02, under 510(k) number K820157.

Who is the listed applicant for XOMED THERMAL MYRINGOTOMY SYSTEM?

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

What is the FDA product code for XOMED THERMAL MYRINGOTOMY SYSTEM?

The FDA product code for XOMED THERMAL MYRINGOTOMY SYSTEM is HQP.

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Other records listing Xomed, Inc. 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.

K002395MODEL 30 CLASSIC PNEUMATONOMETERK002987REDTRONIC XOMED MONOPOLAR ENERGIZED BLADEK002828XPS NITRO SYSTEMK002897TITANIUM MIDDLE EAR PROSTHESESK993653MICRO-FRANCE TROCARS AND ACCESSORIESK001148MEROGEL OTOLOGIC PACK

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Related Devices (Code: HQP)

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.

K121441CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)Bovie Medical CorporationK083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERYFiab SpaK062659KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIESKirwan Surgical Products, Inc.K023506SURGICAL MEDICAL DEVICE CAUTERYModern Medical Equipment Mfg., Ltd.K002547STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTORStarion InstrumentsK994019CAUTERY GRASPER/DISSECTORStarion Instruments

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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