The following data is part of a premarket notification filed by Dana Products, Inc. with the FDA for Steam Sterilization Intergrator.
| Device ID | K012195 |
| 510k Number | K012195 |
| Device Name: | STEAM STERILIZATION INTERGRATOR |
| Classification | Indicator, Physical/chemical Sterilization Process |
| Applicant | DANA PRODUCTS, INC. 7 COREY DR. South Barington, IL 60010 |
| Contact | Harry Bala |
| Correspondent | Harry Bala DANA PRODUCTS, INC. 7 COREY DR. South Barington, IL 60010 |
| Product Code | JOJ |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-13 |
| Decision Date | 2002-05-07 |