Device Classification Name |
Tunneled Catheter Remover
|
510(k) Number |
K122263 |
Device Name |
14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE |
Applicant |
SYMMETRY MEDICAL |
3034 OWEN DRIVE |
ANTIOCH,
TN
37013
|
|
Applicant Contact |
HANNAH FOLEY |
Correspondent |
SYMMETRY MEDICAL |
3034 OWEN DRIVE |
ANTIOCH,
TN
37013
|
|
Correspondent Contact |
HANNAH FOLEY |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 07/27/2012 |
Decision Date | 09/28/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|