The following data is part of a premarket notification filed by Wright Medical Technology, Inc. with the FDA for Atlas Wound Matrix.
Device ID | K090954 |
510k Number | K090954 |
Device Name: | ATLAS WOUND MATRIX |
Classification | Dressing, Wound, Collagen |
Applicant | WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Contact | Ryan M Belaney |
Correspondent | Ryan M Belaney WRIGHT MEDICAL TECHNOLOGY, INC. 5677 AIRLINE RD. Arlington, TN 38002 |
Product Code | KGN |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-06 |
Decision Date | 2009-07-30 |
Summary: | summary |