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FDA 510(k)

ATG/SM-OSA APPLIANCES

K-Number: K130130 · 2013-08-26

ApplicantSelane Products, Inc.
Decision Date2013-08-26
Product CodeLQZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATG/SM-OSA APPLIANCES is the device name listed in this FDA 510(k) record. The listed applicant is Selane Products, Inc.. It received FDA 510(k) clearance on 2013-08-26 under 510(k) number K130130. 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 ATG/SM-OSA APPLIANCES?

ATG/SM-OSA APPLIANCES is a medical device that received FDA 510(k) clearance on 2013-08-26. The listed applicant is Selane Products, Inc.. The 510(k) number is K130130.

When did ATG/SM-OSA APPLIANCES receive FDA 510(k) clearance?

ATG/SM-OSA APPLIANCES received FDA 510(k) clearance on 2013-08-26, under 510(k) number K130130.

Who is the listed applicant for ATG/SM-OSA APPLIANCES?

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

What is the FDA product code for ATG/SM-OSA APPLIANCES?

The FDA product code for ATG/SM-OSA APPLIANCES is LQZ.

Related Clinical Trials

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Other records listing Selane Products, 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.

K162816SML-OSA2 Appliances

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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