Device Classification Name |
Headgear, Extraoral, Orthodontic
|
510(k) Number |
K052553 |
Device Name |
NITOM LOCKING FACEBOW |
Applicant |
RUSSELL SAMUELS ORTHODONTIC DESIGN |
7 CRICKET LANE |
LOUGHBOROUGH, |
LEICESTERSHIRE, ENGLAND,
GB
LE11 3PD
|
|
Applicant Contact |
RUSSELL HENRY ASHLEIGH SAMUELS |
Correspondent |
RUSSELL SAMUELS ORTHODONTIC DESIGN |
7 CRICKET LANE |
LOUGHBOROUGH, |
LEICESTERSHIRE, ENGLAND,
GB
LE11 3PD
|
|
Correspondent Contact |
RUSSELL HENRY ASHLEIGH SAMUELS |
Regulation Number | 872.5500
|
Classification Product Code |
|
Date Received | 09/16/2005 |
Decision Date | 12/22/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|