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 |