The following data is part of a premarket notification filed by Castle Co. with the FDA for Castle Tec-test Steam Steri. Integrator.
| Device ID | K770078 |
| 510k Number | K770078 |
| Device Name: | CASTLE TEC-TEST STEAM STERI. INTEGRATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | CASTLE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-01-13 |
| Decision Date | 1977-02-28 |