ORTHO-WRAP BIORESORBABLE SHEET

Mesh, Surgical, Polymeric

MAST BIOSURGERY

The following data is part of a premarket notification filed by Mast Biosurgery with the FDA for Ortho-wrap Bioresorbable Sheet.

Pre-market Notification Details

Device IDK072190
510k NumberK072190
Device Name:ORTHO-WRAP BIORESORBABLE SHEET
ClassificationMesh, Surgical, Polymeric
Applicant MAST BIOSURGERY 6749 TOP GUN STREET, SUITE 108 San Diego,  CA  92121
ContactKenneth K Kleinhenz
CorrespondentKenneth K Kleinhenz
MAST BIOSURGERY 6749 TOP GUN STREET, SUITE 108 San Diego,  CA  92121
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-06
Decision Date2008-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
18964050475012 K072190 000
18964050472011 K072190 000
00810057380334 K072190 000
00810057380389 K072190 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.