Device Classification Name |
screw, fixation, bone
|
510(k) Number |
K040594 |
Device Name |
HERCULON SOFT TISSUE REATTACHMENT SYSTEM |
Applicant |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Applicant Contact |
CHESTER MCCOY |
Correspondent |
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. |
NORWALK,
CT
06856
|
|
Correspondent Contact |
CHESTER MCCOY |
Regulation Number | 888.3040
|
Classification Product Code |
|
Date Received | 03/08/2004 |
Decision Date | 03/31/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|