The following data is part of a premarket notification filed by Steritec Products, Inc. with the FDA for Cross-checks Dual, Model Ci 125.
| Device ID | K010534 |
| 510k Number | K010534 |
| Device Name: | CROSS-CHECKS DUAL, MODEL CI 125 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 700 Castle Rock, CO 80104 |
| Contact | Linda Nelson |
| Correspondent | Linda Nelson STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 700 Castle Rock, CO 80104 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-23 |
| Decision Date | 2001-08-06 |