The following data is part of a premarket notification filed by Crosstex International, Inc. (a Cantel Medical Company) with the FDA for Crosstex Vh2o2 Chemical Indicators.
| Device ID | K200096 |
| 510k Number | K200096 |
| Device Name: | Crosstex VH2O2 Chemical Indicators |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | Crosstex International, Inc. (A Cantel Medical Company) 6789 W. Henrietta Road Rush, NY 14543 |
| Contact | Pablo Martinez |
| Correspondent | Pablo Martinez Crosstex International, Inc. (A Cantel Medical Company) 10 Ranick Road Hauppauge, NY 11788 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-16 |
| Decision Date | 2021-07-15 |