Device Classification Name |
suture, nonabsorbable, steel, monofilament and multifilament, sterile
|
510(k) Number |
K023594 |
Device Name |
TENO FIX |
Applicant |
ORTHEON MEDICAL, LLC. |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
ORTHEON MEDICAL, LLC. |
555 THIRTEENTH ST. NW |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 878.4495
|
Classification Product Code |
|
Date Received | 10/25/2002 |
Decision Date | 05/15/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|