The following data is part of a premarket notification filed by Otto Bock Health Care, Lp with the FDA for Myosystem With Customizing.
| Device ID | K032833 |
| 510k Number | K032833 |
| Device Name: | MYOSYSTEM WITH CUSTOMIZING |
| Classification | Electrode, Cutaneous |
| Applicant | OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 100 Minneapolis, MN 55447 -4467 |
| Contact | Bert Harman |
| Correspondent | Bert Harman OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 100 Minneapolis, MN 55447 -4467 |
| Product Code | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-11 |
| Decision Date | 2003-09-23 |
| Summary: | summary |