Device Classification Name |
Orthopedic Manual Surgical Instrument
|
510(k) Number |
K941896 |
Device Name |
STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR |
Applicant |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Applicant Contact |
DAVID A KOTKOVETZ |
Correspondent |
DEPUY, INC. |
700 ORTHOPAEDIC DR. |
WARSAW,
IN
46581 -0988
|
|
Correspondent Contact |
DAVID A KOTKOVETZ |
Regulation Number | 888.4540
|
Classification Product Code |
|
Date Received | 04/18/1994 |
Decision Date | 11/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|