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510(k) K253923

Device
PuraStat
Applicant
3-D Matrix Europe SAS
510(k) number
K253923
Product code
PHN
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-07
Date received
2025-12-08
Classification name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Audrey Vion
Address
11 Chemin Des Petites Brosses 2nd Floor Caluire Et Cuire FR 69300 69300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PHN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K242634PuraStat3-D Matrix Europe SAS2025-01-15
K213552PuraStat-RM3-D Matrix, Inc.2022-04-01
K140558PROCTIGARDAccess Pharmaceuticals, Inc.2014-07-16