The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Suresteppro/surestepflexx Professional Blood Glucose Management System.
| Device ID | K023194 |
| 510k Number | K023194 |
| Device Name: | SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | Jojn E Hughes |
| Correspondent | Jojn E Hughes LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | CGA |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-25 |
| Decision Date | 2002-10-24 |
| Summary: | summary |