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FDA 510(k)

PAPARELL TYPE 2, BIOLITE COATED SILI-

K-Number: K800728 · 1980-04-16

ApplicantXomed, Inc.
Decision Date1980-04-16
Product CodeETD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PAPARELL TYPE 2, BIOLITE COATED SILI- is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1980-04-16 under 510(k) number K800728. 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 PAPARELL TYPE 2, BIOLITE COATED SILI-?

PAPARELL TYPE 2, BIOLITE COATED SILI- is a medical device that received FDA 510(k) clearance on 1980-04-16. The listed applicant is Xomed, Inc.. The 510(k) number is K800728.

When did PAPARELL TYPE 2, BIOLITE COATED SILI- receive FDA 510(k) clearance?

PAPARELL TYPE 2, BIOLITE COATED SILI- received FDA 510(k) clearance on 1980-04-16, under 510(k) number K800728.

Who is the listed applicant for PAPARELL TYPE 2, BIOLITE COATED SILI-?

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 PAPARELL TYPE 2, BIOLITE COATED SILI-?

The FDA product code for PAPARELL TYPE 2, BIOLITE COATED SILI- is ETD.

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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: 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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