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FDA 510(k)

PAPPAS TRI-FLANGE VENTILATION TUBE

K-Number: K895242 · 1989-11-17

ApplicantRichards Medical Co., Inc.
Decision Date1989-11-17
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PAPPAS TRI-FLANGE VENTILATION TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Richards Medical Co., Inc.. It received FDA 510(k) clearance on 1989-11-17 under 510(k) number K895242. 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 PAPPAS TRI-FLANGE VENTILATION TUBE?

PAPPAS TRI-FLANGE VENTILATION TUBE is a medical device that received FDA 510(k) clearance on 1989-11-17. The listed applicant is Richards Medical Co., Inc.. The 510(k) number is K895242.

When did PAPPAS TRI-FLANGE VENTILATION TUBE receive FDA 510(k) clearance?

PAPPAS TRI-FLANGE VENTILATION TUBE received FDA 510(k) clearance on 1989-11-17, under 510(k) number K895242.

Who is the listed applicant for PAPPAS TRI-FLANGE VENTILATION TUBE?

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

What is the FDA product code for PAPPAS TRI-FLANGE VENTILATION TUBE?

The FDA product code for PAPPAS TRI-FLANGE VENTILATION TUBE is ETD.

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Other records listing Richards Medical Co., 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.

K896106ROGOZINSKI SPINAL SYSTEM, ADD'L COMPONENTSK900628MODULAR HIP SYSTEMK896580UNI-POLAR HEADK895241INTRAMEDULLARY HIP SCREWK884824TRICON-M TOTAL KNEE SYSTEMK896204ZIRCONIA CERAMIC HEAD ADD'L SIZES

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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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