The following data is part of a premarket notification filed by Steritec Products, Inc. with the FDA for Steritec Container Cord - Ci 135, Steritec Process Indicator Labels - Ci 140, Steritec Process Indicator Dots - Ci 137.
| Device ID | K052516 |
| 510k Number | K052516 |
| Device Name: | STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137 |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-14 |
| Decision Date | 2005-10-03 |