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Parker Quality & Compliance

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510(k) clearance

3M™ Attest™ Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES)

FDA 510(k) source

510(k) number
K261992
Applicant
Solventum US, LLC
Decision date
Sep 25, 2026
Date received
Jun 15, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
JOJ
Device type
Indicator, Physical/Chemical Sterilization Process
Device class
Class II
Regulation
21 CFR 880.2800
Advisory committee
General Hospital
Statement or summary
Summary
Third party
N
Location
San Antonio, TX, US