The following data is part of a premarket notification filed by Steris C/o Medical Device Consultants, Inc. with the FDA for Steris System 1 Processor And 20 Sterilant.
| Device ID | K875280 |
| 510k Number | K875280 |
| Device Name: | STERIS SYSTEM 1 PROCESSOR AND 20 STERILANT |
| Classification | Sterilant, Medical Devices |
| Applicant | STERIS C/O MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | William A Morton |
| Correspondent | William A Morton STERIS C/O MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-24 |
| Decision Date | 1988-09-13 |