The following data is part of a premarket notification filed by Eastern Cranial Affiliates with the FDA for Static Cranioplasty Orthosis.
| Device ID | K020448 |
| 510k Number | K020448 |
| Device Name: | STATIC CRANIOPLASTY ORTHOSIS |
| Classification | Orthosis, Cranial |
| Applicant | EASTERN CRANIAL AFFILIATES 2525 NORTH TENTH ST. # 804 Arlington, VA 22201 |
| Contact | Joseph Terpenning |
| Correspondent | Joseph Terpenning EASTERN CRANIAL AFFILIATES 2525 NORTH TENTH ST. # 804 Arlington, VA 22201 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-11 |
| Decision Date | 2002-04-12 |
| Summary: | summary |