The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Opi Band.
| Device ID | K001167 |
| 510k Number | K001167 |
| Device Name: | OPI BAND |
| Classification | Orthosis, Cranial |
| Applicant | ORTHOMERICA PRODUCTS, INC. 1001 PENNSYLVANIA AVE. NW. 6TH FLOOR Washington, DC 20004 |
| Contact | William H.e. Von Oehsen |
| Correspondent | William H.e. Von Oehsen ORTHOMERICA PRODUCTS, INC. 1001 PENNSYLVANIA AVE. NW. 6TH FLOOR Washington, DC 20004 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-07-07 |