The following data is part of a premarket notification filed by Mast Biosurgery with the FDA for Ortho-wrap Bioresorbable Sheet.
Device ID | K072190 |
510k Number | K072190 |
Device Name: | ORTHO-WRAP BIORESORBABLE SHEET |
Classification | Mesh, Surgical, Polymeric |
Applicant | MAST BIOSURGERY 6749 TOP GUN STREET, SUITE 108 San Diego, CA 92121 |
Contact | Kenneth K Kleinhenz |
Correspondent | Kenneth K Kleinhenz MAST BIOSURGERY 6749 TOP GUN STREET, SUITE 108 San Diego, CA 92121 |
Product Code | FTL |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-06 |
Decision Date | 2008-01-16 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
18964050475012 | K072190 | 000 |
18964050472011 | K072190 | 000 |
00810057380334 | K072190 | 000 |
00810057380389 | K072190 | 000 |