The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steritec Integraph Model Ci-101.
| Device ID | K960441 |
| 510k Number | K960441 |
| Device Name: | STERITEC INTEGRAPH MODEL CI-101 |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 7792 SOUTH URAVAN CT. Aurora, CO 80016 -1847 |
| Contact | Paul A Page |
| Correspondent | Paul A Page STERITEC PRODUCTS MFG. CO., INC. 7792 SOUTH URAVAN CT. Aurora, CO 80016 -1847 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-01 |
| Decision Date | 1997-05-08 |
| Summary: | summary |