The following data is part of a premarket notification filed by Steritec Products, Inc. with the FDA for Sterilization Process Indicator Tapes Model Ci112 & Ci123.
| Device ID | K003002 |
| 510k Number | K003002 |
| Device Name: | STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123 |
| 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 | 2000-09-26 |
| Decision Date | 2000-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10724995044067 | K003002 | 000 |