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FDA 510(k)

PFLEIDERER'S INTRATYMPANIC CATHETER

K-Number: K974008 · 1998-05-13

ApplicantExmoor Plastics , Ltd.
Decision Date1998-05-13
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PFLEIDERER'S INTRATYMPANIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Exmoor Plastics , Ltd.. It received FDA 510(k) clearance on 1998-05-13 under 510(k) number K974008. 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 PFLEIDERER'S INTRATYMPANIC CATHETER?

PFLEIDERER'S INTRATYMPANIC CATHETER is a medical device that received FDA 510(k) clearance on 1998-05-13. The listed applicant is Exmoor Plastics , Ltd.. The 510(k) number is K974008.

When did PFLEIDERER'S INTRATYMPANIC CATHETER receive FDA 510(k) clearance?

PFLEIDERER'S INTRATYMPANIC CATHETER received FDA 510(k) clearance on 1998-05-13, under 510(k) number K974008.

Who is the listed applicant for PFLEIDERER'S INTRATYMPANIC CATHETER?

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

What is the FDA product code for PFLEIDERER'S INTRATYMPANIC CATHETER?

The FDA product code for PFLEIDERER'S INTRATYMPANIC CATHETER is ETD.

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Other records listing Exmoor Plastics , Ltd. 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.

K093863EPIDRUMK990366EXMOOR SUCTION CLEARANCE KITK980828EXMOOR MYRINGOTOMY KITK981143DILKES LASER/SUCTION CANNULAEK972700EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)K981088MILLS COLUMELLA PROSTHESIS

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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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