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 |