The following data is part of a premarket notification filed by Bio-medical Sciences, Inc. with the FDA for Thermalog S Steam Sterilization Integra.
| Device ID | K813202 |
| 510k Number | K813202 |
| Device Name: | THERMALOG S STEAM STERILIZATION INTEGRA |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | BIO-MEDICAL SCIENCES, INC. 101 TECHNOLOGY DR. Bethlehem, PA 18015 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-13 |
| Decision Date | 1981-12-31 |