The following data is part of a premarket notification filed by Carrington Laboratories, Inc. with the FDA for Carrasyn Fdg.
Device ID | K944427 |
510k Number | K944427 |
Device Name: | CARRASYN FDG |
Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
Applicant | CARRINGTON LABORATORIES, INC. 1300 EAST ROCHELLE BLVD. Irving, TX 75062 |
Contact | Dennis R Sparkman |
Correspondent | Dennis R Sparkman CARRINGTON LABORATORIES, INC. 1300 EAST ROCHELLE BLVD. Irving, TX 75062 |
Product Code | MGQ |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-12 |
Decision Date | 1994-11-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CARRASYN FDG 74571468 not registered Dead/Abandoned |
Carrington Laboratories, Inc. 1994-09-09 |