The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Celstat.
Device ID | K103245 |
510k Number | K103245 |
Device Name: | CELSTAT |
Classification | Dressing, Wound, Drug |
Applicant | BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
Contact | Samuel Mathew |
Correspondent | Samuel Mathew BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park, IL 60085 |
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 | 2010-11-02 |
Decision Date | 2011-03-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CELSTAT 85402352 4317920 Dead/Cancelled |
Baxter International Inc. 2011-08-19 |