The following data is part of a premarket notification filed by Otto Bock Healthcare Lp with the FDA for Mycro Band.
| Device ID | K201426 |
| 510k Number | K201426 |
| Device Name: | MyCRO Band |
| Classification | Orthosis, Cranial |
| Applicant | Otto Bock Healthcare LP 3820 West Great Lakes Drive Salt Lake City, UT 84120 |
| Contact | Caleb Beck |
| Correspondent | Adrienne Von Foller Strategic Quality Solutions, LLC 1594 E Monaco Ave Salt Lake City, UT 84121 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-29 |
| Decision Date | 2021-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04064409000104 | K201426 | 000 |
| 04064409000029 | K201426 | 000 |
| 04064409000036 | K201426 | 000 |
| 04064409000043 | K201426 | 000 |
| 04064409000050 | K201426 | 000 |
| 04064409000067 | K201426 | 000 |
| 04064409000074 | K201426 | 000 |
| 04064409000081 | K201426 | 000 |
| 04064409000098 | K201426 | 000 |
| 04064409000012 | K201426 | 000 |