Device Classification Name |
mesh, surgical, acetabular, hip, prosthesis
|
510(k) Number |
K963940 |
Device Name |
EXETER MESH |
Applicant |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Applicant Contact |
FRANK MAAS |
Correspondent |
HOWMEDICA, INC. |
359 VETERANS BLVD. |
RUTHERFORD,
NJ
07070
|
|
Correspondent Contact |
FRANK MAAS |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/01/1996 |
Decision Date | 02/13/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|