Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K071016 |
Device Name |
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
KATHY HARRIS |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
KATHY HARRIS |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 04/10/2007 |
Decision Date | 09/04/2007 |
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
|
|
|