Device Classification Name |
Cord, Retraction
|
510(k) Number |
K091380 |
Device Name |
CORDCAP |
Applicant |
CENTRIX, INC. |
770 RIVER RD. |
SHELTON,
CT
06484 -5458
|
|
Applicant Contact |
JOHN DISCKO |
Correspondent |
CENTRIX, INC. |
770 RIVER RD. |
SHELTON,
CT
06484 -5458
|
|
Correspondent Contact |
JOHN DISCKO |
Classification Product Code |
|
Date Received | 05/11/2009 |
Decision Date | 07/30/2009 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|