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FDA 510(k)

OTOLOGICAL VENTILATION TUBES

K-Number: K802638 · 1980-11-12

ApplicantSanta Barbara Medco, Inc.
Decision Date1980-11-12
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OTOLOGICAL VENTILATION TUBES is the device name listed in this FDA 510(k) record. The listed applicant is Santa Barbara Medco, Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802638. The device is classified under product code ETD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTOLOGICAL VENTILATION TUBES?

OTOLOGICAL VENTILATION TUBES is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Santa Barbara Medco, Inc.. The 510(k) number is K802638.

When did OTOLOGICAL VENTILATION TUBES receive FDA 510(k) clearance?

OTOLOGICAL VENTILATION TUBES received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802638.

Who is the listed applicant for OTOLOGICAL VENTILATION TUBES?

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

What is the FDA product code for OTOLOGICAL VENTILATION TUBES?

The FDA product code for OTOLOGICAL VENTILATION TUBES is ETD.

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Other records listing Santa Barbara Medco, Inc. as applicant

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Related Devices (Code: ETD)

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.

K252436Tula Tympanostomy Tube Delivery DeviceTusker Medical, Inc.K250256Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))Aventamed DacK232702Solo+ Tympanostomy Tube Device (TTD)Aventamed DacK233658Biowy Tym Tube (TT)Biowy CorporationK232059Tympanostomy TubesGrace Medical, Inc.K221254Hummingbird Tympanostomy Tube SystemPreceptis 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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