The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Miromatrix Biological Mesh Rs.
Device ID | K150341 |
510k Number | K150341 |
Device Name: | Miromatrix Biological Mesh RS |
Classification | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery |
Applicant | MIROMATRIX MEDICAL INC. 18683 Bearpath Trail Eden Prairie, MN 55347 |
Contact | Jeff Ross |
Correspondent | Miriam C. Provost BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON STREET SUITE 100 Alexandria, VA 22314 |
Product Code | OXH |
CFR Regulation Number | 878.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-11 |
Decision Date | 2015-05-12 |
Summary: | summary |