The following data is part of a premarket notification filed by Orthotic Care Services, Llp with the FDA for Cranial Remolding Orthosis.
| Device ID | K111247 |
| 510k Number | K111247 |
| Device Name: | CRANIAL REMOLDING ORTHOSIS |
| Classification | Orthosis, Cranial |
| Applicant | ORTHOTIC CARE SERVICES, LLP 360 SHERMAN STREET, SUITE 299 St.paul, MN 55102 |
| Contact | Scott Hinshon |
| Correspondent | Scott Hinshon ORTHOTIC CARE SERVICES, LLP 360 SHERMAN STREET, SUITE 299 St.paul, MN 55102 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-03 |
| Decision Date | 2011-08-15 |
| Summary: | summary |