Device Classification Name |
Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
|
510(k) Number |
K960711 |
Device Name |
ACUMED BONE GRAFT SYSTEM |
Applicant |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Applicant Contact |
SHARI L JEFFERS |
Correspondent |
ACUMED, INC. |
10950 S.W. 5TH ST. |
SUITE 170 |
BEAVERTON,
OR
97005
|
|
Correspondent Contact |
SHARI L JEFFERS |
Regulation Number | 878.4820
|
Classification Product Code |
|
Date Received | 02/21/1996 |
Decision Date | 05/07/1996 |
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
|
|
|