Device Classification Name |
Suture, Nonabsorbable, Synthetic, Polyethylene
|
510(k) Number |
K042038 |
Device Name |
MTF ALLOGRAFT ANCHOR |
Applicant |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
9109 COPENHAVER DRIVE |
POTOMAC,
MD
20854
|
|
Applicant Contact |
NORMAN F ESTRIN |
Correspondent |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
9109 COPENHAVER DRIVE |
POTOMAC,
MD
20854
|
|
Correspondent Contact |
NORMAN F ESTRIN |
Regulation Number | 878.5000
|
Classification Product Code |
|
Date Received | 07/29/2004 |
Decision Date | 12/23/2004 |
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 |
Yes
|
|
|