The following data is part of a premarket notification filed by Steritec Products, Inc. with the FDA for Steritec Emu-graph, Model No. Ci 131/us.
| Device ID | K040901 |
| 510k Number | K040901 |
| Device Name: | STERITEC EMU-GRAPH, MODEL NO. CI 131/US |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 400 Castle Rock, CO 80109 |
| Contact | Linda Nelson |
| Correspondent | Linda Nelson STERITEC PRODUCTS, INC. 599 TOPEKA WAY, SUITE 400 Castle Rock, CO 80109 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-07 |
| Decision Date | 2004-09-09 |