The following data is part of a premarket notification filed by Castle Co. with the FDA for Castle Tec-test S.m.a.r.t. Pack.
| Device ID | K833074 |
| 510k Number | K833074 |
| Device Name: | CASTLE TEC-TEST S.M.A.R.T. PACK |
| 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 | 1983-09-09 |
| Decision Date | 1983-11-07 |