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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Forza

FDA 510(k) source

510(k) number
K260136
Applicant
True Function Laboratory, Inc.
Decision date
Oct 6, 2026
Date received
Jan 16, 2026
Decision
Substantially Equivalent
Clearance type
Abbreviated
Product code
LRK
Device type
Device, Anti-Snoring
Device class
Class II
Regulation
21 CFR 872.5570
Advisory committee
Dental
Statement or summary
Summary
Third party
N
Location
La Mesa, CA, US