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FDA 510(k)

SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE

K-Number: K071404 · 2007-08-17

ApplicantPower Products, Inc.-Splintek
Decision Date2007-08-17
Product CodeMQC
DecisionSubstantially Equivalent

Device Summary

SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE is the device name listed in this FDA 510(k) record. The listed applicant is Power Products, Inc.-Splintek. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K071404. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE?

SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is Power Products, Inc.-Splintek. The 510(k) number is K071404.

When did SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE receive FDA 510(k) clearance?

SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE received FDA 510(k) clearance on 2007-08-17, under 510(k) number K071404.

Who is the listed applicant for SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE?

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

What is the FDA product code for SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE?

The FDA product code for SLEEP RIGHT - SELECT, LOW PROFILE AND ADVANCE is MQC.

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Other records listing Power Products, Inc.-Splintek 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.

K100545SLEEPRIGHTK022809EZ SPLINT & EZ SPLINT PM

Related Devices (Code: MQC)

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.

K253798UltraPrint-Dental Hard Splint UVGuangzhou Heygears IMC., Inc.K250743Remvia NightGuardRemviaK251252NOBILCAM IMPAK DiscShandong Huge Dental Material CorporationK241729Hard Splint & Thermo-Adaptive SplintWhip Mix CorporationK243516Remi Custom Night GuardGrindguard, Inc.K241369LIJIA Night GuardLijia, LLC

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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