The following data is part of a premarket notification filed by Becker Orthopedic Appliance Co. with the FDA for Becker Band Cranial Remolding Orthosis.
| Device ID | K013719 |
| 510k Number | K013719 |
| Device Name: | BECKER BAND CRANIAL REMOLDING ORTHOSIS |
| Classification | Orthosis, Cranial |
| Applicant | BECKER ORTHOPEDIC APPLIANCE CO. 635 EXECUTIVE DR. Troy, MI 48083 |
| Contact | James H Campbell |
| Correspondent | James H Campbell BECKER ORTHOPEDIC APPLIANCE CO. 635 EXECUTIVE DR. Troy, MI 48083 |
| Product Code | MVA |
| CFR Regulation Number | 882.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-08 |
| Decision Date | 2002-02-05 |
| Summary: | summary |