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FDA 510(k)

ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE

K-Number: K971794 · 1997-09-29

ApplicantFrantz Design, Inc.
Decision Date1997-09-29
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Frantz Design, Inc.. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K971794. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE?

ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Frantz Design, Inc.. The 510(k) number is K971794.

When did ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE receive FDA 510(k) clearance?

ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE received FDA 510(k) clearance on 1997-09-29, under 510(k) number K971794.

Who is the listed applicant for ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE?

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

What is the FDA product code for ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE?

The FDA product code for ELASTIC MANDIBULAR ADVANCEMENT (EMA) APPLIANCE is LRK.

Related Clinical Trials

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Other records listing Frantz Design, 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.

K973884ELASTIC MANDIBULAR ADVANCEMENT - TITRATION (EMA-T) APPILANCE

Related Devices (Code: LRK)

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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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