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FDA 510(k)

MEROGEL CONTROL GEL ENT SURGICAL DRESSING

K-Number: K002972 · 2000-12-15

ApplicantMedtronic Xomed
Decision Date2000-12-15
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROGEL CONTROL GEL ENT SURGICAL DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed. It received FDA 510(k) clearance on 2000-12-15 under 510(k) number K002972. 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 MEROGEL CONTROL GEL ENT SURGICAL DRESSING?

MEROGEL CONTROL GEL ENT SURGICAL DRESSING is a medical device that received FDA 510(k) clearance on 2000-12-15. The listed applicant is Medtronic Xomed. The 510(k) number is K002972.

When did MEROGEL CONTROL GEL ENT SURGICAL DRESSING receive FDA 510(k) clearance?

MEROGEL CONTROL GEL ENT SURGICAL DRESSING received FDA 510(k) clearance on 2000-12-15, under 510(k) number K002972.

Who is the listed applicant for MEROGEL CONTROL GEL ENT SURGICAL DRESSING?

The FDA 510(k) record lists Medtronic Xomed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEROGEL CONTROL GEL ENT SURGICAL DRESSING?

The FDA product code for MEROGEL CONTROL GEL ENT SURGICAL DRESSING is KHJ.

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Other records listing Medtronic Xomed 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.

K202623Novapak Nasal Sinus Packing and StentK122434MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GELK031510NIM-SPINEK002224XPS 3000 SYSTEMK000728MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBEK990793ACCUGUIDE MUSCLE INJECTION MONITOR

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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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