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FDA 510(k)

JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT

K-Number: K060815 · 2006-04-18

ApplicantBioform Medical, Inc.
Decision Date2006-04-18
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Bioform Medical, Inc.. It received FDA 510(k) clearance on 2006-04-18 under 510(k) number K060815. The device is classified under product code MIX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT?

JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT is a medical device that received FDA 510(k) clearance on 2006-04-18. The listed applicant is Bioform Medical, Inc.. The 510(k) number is K060815.

When did JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT receive FDA 510(k) clearance?

JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT received FDA 510(k) clearance on 2006-04-18, under 510(k) number K060815.

Who is the listed applicant for JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT?

The FDA 510(k) record lists Bioform Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT?

The FDA product code for JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT is MIX.

Related Clinical Trials

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Other records listing Bioform Medical, 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.

K081729MODIFICATION TO GFX NERVE ABLATION SYSTEMK070090RADIESSE LARYNGEAL IMPLANT

Related Devices (Code: MIX)

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.

K240919Silk Voice (SMI-04)Sofregen MedicalK180631Silk VoiceSofregen Medical, Inc.K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTCytophil, Inc.K083783VF LIQUIGELCoapt Systems, Inc.K081815VOCALIS GELCytophil, Inc.K081816VOCALIS AND VOCALIS SMCytophil, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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