The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Chloraprep.
Device ID | K021131 |
510k Number | K021131 |
Device Name: | CHLORAPREP |
Classification | Varnish, Cavity |
Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Contact | John Discko |
Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-08 |
Decision Date | 2002-09-26 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
CHLORAPREP 85291579 4052849 Live/Registered |
Carefusion 2200, Inc. 2011-04-11 |
CHLORAPREP 74460998 1930248 Live/Registered |
CAREFUSION 2200, INC. 1993-11-22 |