Device Classification Name |
arthroscope
|
510(k) Number |
K012611 |
Device Name |
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS |
Applicant |
ALLIANCE MEDICAL, INC. |
10232 SOUTH 51 ST. |
PHOENIX,
AZ
85044
|
|
Applicant Contact |
DON SELVEY |
Correspondent |
ALLIANCE MEDICAL, INC. |
10232 SOUTH 51 ST. |
PHOENIX,
AZ
85044
|
|
Correspondent Contact |
DON SELVEY |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 08/13/2001 |
Decision Date | 11/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|