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FDA 510(k)

POPE OTO-WICK, STERILE & NON-STERILE

K-Number: K791059 · 1979-07-17

ApplicantXomed, Inc.
Decision Date1979-07-17
Product CodeKCN
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

POPE OTO-WICK, STERILE & NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1979-07-17 under 510(k) number K791059. The device is classified under product code KCN. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POPE OTO-WICK, STERILE & NON-STERILE?

POPE OTO-WICK, STERILE & NON-STERILE is a medical device that received FDA 510(k) clearance on 1979-07-17. The listed applicant is Xomed, Inc.. The 510(k) number is K791059.

When did POPE OTO-WICK, STERILE & NON-STERILE receive FDA 510(k) clearance?

POPE OTO-WICK, STERILE & NON-STERILE received FDA 510(k) clearance on 1979-07-17, under 510(k) number K791059.

Who is the listed applicant for POPE OTO-WICK, STERILE & NON-STERILE?

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 POPE OTO-WICK, STERILE & NON-STERILE?

The FDA product code for POPE OTO-WICK, STERILE & NON-STERILE is KCN.

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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: KCN)

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.

K062540NASOPORE EAR, MODELS ND04, ND05Polyganics B.V.,K973578INVOTEC EAR TAMPON (WICK) W/STRINGInvotec International, Inc.K920357ULTRACELL EAR WICKUltracell Medical Technologies, 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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