Device Classification Name |
arthroscope
|
510(k) Number |
K022199 |
Device Name |
ENDIUS ATAVI SYSTEM |
Applicant |
ENDIUS, INC. |
23 WEST BACON ST. |
PLAINVILLE,
MA
02762
|
|
Applicant Contact |
CHRISTINE KUNTZ NASSIF |
Correspondent |
ENDIUS, INC. |
23 WEST BACON ST. |
PLAINVILLE,
MA
02762
|
|
Correspondent Contact |
CHRISTINE KUNTZ NASSIF |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 07/05/2002 |
Decision Date | 10/02/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|