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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Classification Name: PROTECTIVE COATING, MUCOADHESIVE APPLICATION, FOR THE RECTAL MUCOSA
Product Code: PHN
Device Class: Unclassified
Registered Establishment Name: 3-D MATRIX EUROPE SAS
Registered Establishment Number: 3012263097
Premarket Submission Number: K242634
Owner/Operator: 3-D MATRIX EUROPE SAS
Owner/Operator Number: 10084567
Establishment Operations: Manufacturer; Complaint File Establishment
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