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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Everslide

FDA 510(k) source

510(k) number
K260117
Applicant
Special Situations, LLC
Decision date
Sep 23, 2026
Date received
Jan 14, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
NUC
Device type
Lubricant, Personal
Device class
Class II
Regulation
21 CFR 884.5300
Advisory committee
Obstetrics/Gynecology
Statement or summary
Summary
Third party
N
Location
Tulsa, OK, US