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FDA 510(k)

EPIFILM OTOLOGIC LAMINA

K-Number: K982870 · 1998-11-03

ApplicantXomed, Inc.
Decision Date1998-11-03
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EPIFILM OTOLOGIC LAMINA is the device name listed in this FDA 510(k) record. The listed applicant is Xomed, Inc.. It received FDA 510(k) clearance on 1998-11-03 under 510(k) number K982870. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIFILM OTOLOGIC LAMINA?

EPIFILM OTOLOGIC LAMINA is a medical device that received FDA 510(k) clearance on 1998-11-03. The listed applicant is Xomed, Inc.. The 510(k) number is K982870.

When did EPIFILM OTOLOGIC LAMINA receive FDA 510(k) clearance?

EPIFILM OTOLOGIC LAMINA received FDA 510(k) clearance on 1998-11-03, under 510(k) number K982870.

Who is the listed applicant for EPIFILM OTOLOGIC LAMINA?

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 EPIFILM OTOLOGIC LAMINA?

The FDA product code for EPIFILM OTOLOGIC LAMINA is KHJ.

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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: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK122561ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAINCeremed , 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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