The following data is part of a premarket notification filed by Advanced Orthopro Inc. with the FDA for Aoi Cranial Helmet.
| Device ID | K103362 |
| 510k Number | K103362 |
| Device Name: | AOI CRANIAL HELMET |
| Classification | Orthosis, Cranial |
| Applicant | ADVANCED ORTHOPRO INC. 1820 N. ILLINOIS ST. Indianapolis, IN 46202 |
| Contact | Mohamad Mansoori |
| Correspondent | Mohamad Mansoori ADVANCED ORTHOPRO INC. 1820 N. ILLINOIS ST. Indianapolis, IN 46202 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-17 |
| Decision Date | 2011-04-18 |
| Summary: | summary |