The following data is part of a premarket notification filed by Orthomerica Products, Inc. with the FDA for Starband Cranial Orthosis.
| Device ID | K011350 |
| 510k Number | K011350 |
| Device Name: | STARBAND CRANIAL ORTHOSIS |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | ORTHOMERICA PRODUCTS, INC. 1001 PENNSYLVANIA AVE. 6TH FLOOR Washington, DC 20004 |
| Contact | William H Von Oehsen |
| Correspondent | William H Von Oehsen ORTHOMERICA PRODUCTS, INC. 1001 PENNSYLVANIA AVE. 6TH FLOOR Washington, DC 20004 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-02 |
| Decision Date | 2001-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B151709A0 | K011350 | 000 |
| B15170906A0 | K011350 | 000 |
| B151704A0 | K011350 | 000 |
| B15170406A0 | K011350 | 000 |
| B151703A0 | K011350 | 000 |
| B15170306A0 | K011350 | 000 |