Device Classification Name |
arthroscope
|
510(k) Number |
K122411 |
Device Name |
J-SCOPE SYSTEM |
Applicant |
MYELOTEC |
2600 MULLINIX MILL ROAD |
MT. AIRY,
MD
21771
|
|
Applicant Contact |
BLIX WINSTON |
Correspondent |
MYELOTEC |
2600 MULLINIX MILL ROAD |
MT. AIRY,
MD
21771
|
|
Correspondent Contact |
BLIX WINSTON |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 08/08/2012 |
Decision Date | 02/11/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|