The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steam/eo Record Card, Model Ci 121.
| Device ID | K000502 |
| 510k Number | K000502 |
| Device Name: | STEAM/EO RECORD CARD, MODEL CI 121 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 599 TOPEKA WAY SUITE 700 Castle Rock, CO 80104 |
| Contact | Linda Nelson |
| Correspondent | Linda Nelson STERITEC PRODUCTS MFG. CO., INC. 599 TOPEKA WAY SUITE 700 Castle Rock, CO 80104 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-15 |
| Decision Date | 2000-03-14 |