Device Classification Name |
Syringe, Cartridge
|
510(k) Number |
K120659 |
Device Name |
HU-FRIEDY DENTAL CARTRIDGE SYRINGE |
Applicant |
HU-FRIEDY MFG. CO. LLC |
3232 N ROCKWELL STREET |
CHICAGO,
IL
60618
|
|
Applicant Contact |
MARIA VRABIE |
Correspondent |
HU-FRIEDY MFG. CO. LLC |
3232 N ROCKWELL STREET |
CHICAGO,
IL
60618
|
|
Correspondent Contact |
MARIA VRABIE |
Regulation Number | 872.6770
|
Classification Product Code |
|
Date Received | 03/05/2012 |
Decision Date | 11/06/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|