Device Classification Name |
Handpiece, Air-Powered, Dental
|
510(k) Number |
K052700 |
Device Name |
PANA-SPRAY |
Applicant |
NSK AMERICA CORP. |
700-B COOPER CT. |
SCHAUMBURG,
IL
60173
|
|
Applicant Contact |
HIROHIKO MURASE |
Correspondent |
NSK AMERICA CORP. |
700-B COOPER CT. |
SCHAUMBURG,
IL
60173
|
|
Correspondent Contact |
HIROHIKO MURASE |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 09/28/2005 |
Decision Date | 12/20/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|