Device Classification Name |
handpiece, air-powered, dental
|
510(k) Number |
K132478 |
Device Name |
AIR-FLOW HANDY 3.0 |
Applicant |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
62 FOREST ST., STE 300 |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
CYNTHIA J NOLTE |
Correspondent |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
62 FOREST ST., STE 300 |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
CYNTHIA J NOLTE |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 08/08/2013 |
Decision Date | 04/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|