The following data is part of a premarket notification filed by Maxigen Biotech, Inc. with the FDA for Surgiaid.
Device ID | K100927 |
510k Number | K100927 |
Device Name: | SURGIAID |
Classification | Dressing, Wound, Collagen |
Applicant | MAXIGEN BIOTECH, INC. 2904 N BOLDT AVE Flagstaff, AZ 86001 |
Contact | Jennifer Reich |
Correspondent | Jennifer Reich MAXIGEN BIOTECH, INC. 2904 N BOLDT AVE Flagstaff, AZ 86001 |
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 | 2010-04-05 |
Decision Date | 2011-02-02 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SURGIAID 75665858 2635824 Dead/Cancelled |
MBI Biotech (USA), Inc. 1999-03-22 |