The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steritec Disposable Integrator Load Challenge-steam.
| Device ID | K965212 |
| 510k Number | K965212 |
| Device Name: | STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY, STE #600 Castle Rock, CO 80104 |
| Contact | Tom Roll |
| Correspondent | Tom Roll STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY, STE #600 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 | 1996-12-27 |
| Decision Date | 1998-04-23 |
| Summary: | summary |