Device Classification Name |
Blade, Saw, General & Plastic Surgery, Surgical
|
510(k) Number |
K971978 |
Device Name |
GRAFT HARVESTING SAWBLADES |
Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Applicant Contact |
CRISTIE MANUEL |
Correspondent |
WRIGHT MEDICAL TECHNOLOGY, INC. |
5677 AIRLINE RD. |
ARLINGTON,
TN
38002
|
|
Correspondent Contact |
CRISTIE MANUEL |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 05/29/1997 |
Decision Date | 06/18/1997 |
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
|
|
|