Device Classification Name |
arthroscope
|
510(k) Number |
K122134 |
Device Name |
FLEXLITE CAMERA |
Applicant |
SPINE VIEW, INC. |
48810 Kato Rd. Suite 100E |
Fremont,
CA
94538
|
|
Applicant Contact |
MBITHI MUTHINI |
Correspondent |
SPINE VIEW, INC. |
48810 Kato Rd. Suite 100E |
Fremont,
CA
94538
|
|
Correspondent Contact |
MBITHI MUTHINI |
Regulation Number | 888.1100
|
Classification Product Code |
|
Date Received | 07/18/2012 |
Decision Date | 12/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|