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FDA 510(k)

FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

K-Number: K091035 · 2009-06-24

ApplicantBryan Keropian Dds
Decision Date2009-06-24
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FULL BREATH SLEEP APPLIANCE LOWER (FBSL) is the device name listed in this FDA 510(k) record. The listed applicant is Bryan Keropian Dds. It received FDA 510(k) clearance on 2009-06-24 under 510(k) number K091035. The device is classified under product code LQZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FULL BREATH SLEEP APPLIANCE LOWER (FBSL)?

FULL BREATH SLEEP APPLIANCE LOWER (FBSL) is a medical device that received FDA 510(k) clearance on 2009-06-24. The listed applicant is Bryan Keropian Dds. The 510(k) number is K091035.

When did FULL BREATH SLEEP APPLIANCE LOWER (FBSL) receive FDA 510(k) clearance?

FULL BREATH SLEEP APPLIANCE LOWER (FBSL) received FDA 510(k) clearance on 2009-06-24, under 510(k) number K091035.

Who is the listed applicant for FULL BREATH SLEEP APPLIANCE LOWER (FBSL)?

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

What is the FDA product code for FULL BREATH SLEEP APPLIANCE LOWER (FBSL)?

The FDA product code for FULL BREATH SLEEP APPLIANCE LOWER (FBSL) is LQZ.

Related Clinical Trials

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Other records listing Bryan Keropian Dds 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.

K061228FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSORK053065FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)K052862FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)

Related Devices (Code: LQZ)

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.

K233754AIO BreatheAiomega, LLCK230532RADx Intraoral Appliance for Snoring and Sleep ApneaAchaemenid, LLCK203712The SlideBiotex, Inc.K191320Slow Wave DS8Slow Wave, Inc.K192581The NightBlocks ApplianceAdvanced Facialdontics, LLCK162816SML-OSA2 AppliancesSelane Products, 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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