The following data is part of a premarket notification filed by Hanger Prosthetics & Orthotics, Inc. with the FDA for Hanger Cranial Band.
| Device ID | K072566 |
| 510k Number | K072566 |
| Device Name: | HANGER CRANIAL BAND |
| Classification | Orthosis, Cranial, Laser Scan |
| Applicant | HANGER PROSTHETICS & ORTHOTICS, INC. 700 12TH STREET, NW Washington, DC 20005 |
| Contact | Ivan J Wasserman |
| Correspondent | Ivan J Wasserman HANGER PROSTHETICS & ORTHOTICS, INC. 700 12TH STREET, NW Washington, DC 20005 |
| Product Code | OAN |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-12 |
| Decision Date | 2008-01-09 |
| Summary: | summary |