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510(k) K242634

Device
PuraStat
Applicant
3-D Matrix Europe SAS
510(k) number
K242634
Product code
PHN
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-15
Date received
2024-09-03
Classification name
Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Audrey Vion
Address
11 Chemin Des Petites Brosses 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
K253923PuraStat3-D Matrix Europe SAS2026-01-07
K213552PuraStat-RM3-D Matrix, Inc.2022-04-01
K140558PROCTIGARDAccess Pharmaceuticals, Inc.2014-07-16