Device Classification Name |
handpiece, air-powered, dental
|
510(k) Number |
K082791 |
Device Name |
EMS AIR-FLOW MASTER |
Applicant |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
49 PLAIN ST |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
CYNTHIA J NOLTE |
Correspondent |
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
49 PLAIN ST |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
CYNTHIA J NOLTE |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 09/23/2008 |
Decision Date | 02/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|