The following data is part of a premarket notification filed by Advanced Sterilization Products with the FDA for Evotech Integrated Endoscope Disinfection System.
| Device ID | K040883 |
| 510k Number | K040883 |
| Device Name: | EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Contact | Neelu Medhekar |
| Correspondent | Neelu Medhekar ADVANCED STERILIZATION PRODUCTS 33 TECHNOLOGY DR. Irvine, CA 92618 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-05 |
| Decision Date | 2005-03-15 |
| Summary: | summary |