Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K001738 |
Device Name |
DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
Applicant |
DEPUY ORTHOPAEDICS, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
MARCIA J ARENTZ |
Correspondent |
DEPUY ORTHOPAEDICS, INC. |
P.O. BOX 988 |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
MARCIA J ARENTZ |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 06/07/2000 |
Decision Date | 12/27/2000 |
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
|
|
|