The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for St. Louis Band.
| Device ID | K161138 |
| 510k Number | K161138 |
| Device Name: | St. Louis Band |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810 |
| Contact | David C. Kerr |
| Correspondent | David L. Hooper ORTHOMERICA PRODUCTS, INC. 6333 NORTH ORANGE BLOSSOM TRAIL Orlando, FL 32810 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-22 |
| Decision Date | 2016-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B15176308PA0 | K161138 | 000 |
| B15176308A0 | K161138 | 000 |
| B15170908PA0 | K161138 | 000 |
| B15170908A0 | K161138 | 000 |
| B15170408PA0 | K161138 | 000 |
| B15170408A0 | K161138 | 000 |