The following data is part of a premarket notification filed by Biotime, Inc. with the FDA for Premvia.
| Device ID | K134037 |
| 510k Number | K134037 |
| Device Name: | PREMVIA |
| Classification | Dressing, Wound, Collagen |
| Applicant | BIOTIME, INC. 8708 CAPEHART COVE Austin, TX 78733 |
| Contact | David C Furr |
| Correspondent | David C Furr BIOTIME, INC. 8708 CAPEHART COVE Austin, TX 78733 |
| 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 | 2013-12-31 |
| Decision Date | 2014-08-07 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PREMVIA 87440330 not registered Live/Pending |
BioTime, Inc. 2017-05-08 |
![]() PREMVIA 86064033 not registered Dead/Abandoned |
BioTime, Inc. 2013-09-13 |