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 |