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FDA 510(k)

PRELUDE III TONGUE SUSPENSION SYSTEM

K-Number: K110127 · 2011-04-08

ApplicantSiesta Medical, Inc.
Decision Date2011-04-08
Product CodeORY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRELUDE III TONGUE SUSPENSION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Siesta Medical, Inc.. It received FDA 510(k) clearance on 2011-04-08 under 510(k) number K110127. The device is classified under product code ORY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRELUDE III TONGUE SUSPENSION SYSTEM?

PRELUDE III TONGUE SUSPENSION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-04-08. The listed applicant is Siesta Medical, Inc.. The 510(k) number is K110127.

When did PRELUDE III TONGUE SUSPENSION SYSTEM receive FDA 510(k) clearance?

PRELUDE III TONGUE SUSPENSION SYSTEM received FDA 510(k) clearance on 2011-04-08, under 510(k) number K110127.

Who is the listed applicant for PRELUDE III TONGUE SUSPENSION SYSTEM?

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

What is the FDA product code for PRELUDE III TONGUE SUSPENSION SYSTEM?

The FDA product code for PRELUDE III TONGUE SUSPENSION SYSTEM is ORY.

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Other records listing Siesta 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.

K213159Encore SystemK201238Encore SystemK183310Encore SystemK121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITK121814ENCORE TONGUE SUSPENSION SYSTEMK111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN

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Related Devices (Code: ORY)

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.

K213159Encore SystemSiesta Medical, Inc.K201238Encore SystemSiesta Medical, Inc.K183310Encore SystemSiesta Medical, Inc.K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITSiesta Medical, Inc.K121814ENCORE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.K111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMENSiesta Medical, 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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