The following data is part of a premarket notification filed by Macropore Biosurgery, Inc. with the FDA for Macropore Surgi-wrap Mast Bioresorbable Sheet.
Device ID | K031955 |
510k Number | K031955 |
Device Name: | MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET |
Classification | Mesh, Surgical, Polymeric |
Applicant | MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. San Diego, CA 92121 |
Contact | Kenneth K Kleinhenz |
Correspondent | Kenneth K Kleinhenz MACROPORE BIOSURGERY, INC. 6740 TOP GUN ST. 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 | 2003-06-25 |
Decision Date | 2003-09-22 |
Summary: | summary |