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FDA 510(k)

DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE

K-Number: K051487 · 2005-12-22

ApplicantDoctor'S Research Group, Inc.
Decision Date2005-12-22
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Doctor'S Research Group, Inc.. It received FDA 510(k) clearance on 2005-12-22 under 510(k) number K051487. 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 DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE?

DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE is a medical device that received FDA 510(k) clearance on 2005-12-22. The listed applicant is Doctor'S Research Group, Inc.. The 510(k) number is K051487.

When did DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE receive FDA 510(k) clearance?

DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE received FDA 510(k) clearance on 2005-12-22, under 510(k) number K051487.

Who is the listed applicant for DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE?

The FDA 510(k) record lists Doctor'S Research Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE?

The FDA product code for DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE is KHJ.

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Other records listing Doctor'S Research Group, 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.

K041018DRG SOFTRELEASEK012535DRG DISPOSABLE VAGINAL SPECULUMK012003DRG REACTION CHAMBER/SAFETY TIPK011736DRG QUICKMIXK013786DRG ORTHOHEX SS BONE SCREWK002047DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2

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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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