The following data is part of a premarket notification filed by Steritec Products Mfg. Co., Inc. with the FDA for Steritec Disposable Biological Test Pack-eo Gas.
| Device ID | K981497 |
| 510k Number | K981497 |
| Device Name: | STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
| Contact | Tom Roll |
| Correspondent | Tom Roll STERITEC PRODUCTS MFG. CO., INC. 680 ATCHISON WAY SUITE 600 Castle Rock, CO 80104 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-27 |
| Decision Date | 1998-10-29 |
| Summary: | summary |