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 |