Device Classification Name |
mesh, surgical
|
510(k) Number |
K982330 |
Device Name |
DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
Applicant |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
CHERYL K HASTINGS |
Correspondent |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
CHERYL K HASTINGS |
Regulation Number | 878.3300
|
Classification Product Code |
|
Date Received | 07/02/1998 |
Decision Date | 09/25/1998 |
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
|
|
|