The following data is part of a premarket notification filed by Tri-state Hospital Supply Corp. with the FDA for Centurion Sorbaview Otc.
Device ID | K080524 |
510k Number | K080524 |
Device Name: | CENTURION SORBAVIEW OTC |
Classification | Dressing, Wound, Drug |
Applicant | TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
Contact | Matthew K Price |
Correspondent | Matthew K Price TRI-STATE HOSPITAL SUPPLY CORP. 301 CATRELL DR. Howell, MI 48843 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-02-26 |
Decision Date | 2008-04-23 |
Summary: | summary |