Device Classification Name |
Cement, Dental
|
510(k) Number |
K050658 |
Device Name |
RESO-PAC PERIODONTAL DRESSING |
Applicant |
HAGER WORLDWIDE, INC. |
2000 M STREET, N.W. 7TH FLOOR |
WASHINGTON,
DC
20036 -3307
|
|
Applicant Contact |
DANIEL J MANELLI |
Correspondent |
HAGER WORLDWIDE, INC. |
2000 M STREET, N.W. 7TH FLOOR |
WASHINGTON,
DC
20036 -3307
|
|
Correspondent Contact |
DANIEL J MANELLI |
Regulation Number | 872.3275
|
Classification Product Code |
|
Date Received | 03/14/2005 |
Decision Date | 05/27/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|